Clinical Study Synopsis for Public Disclosure

Size: px
Start display at page:

Download "Clinical Study Synopsis for Public Disclosure"

Transcription

1 abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical study report - had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non-approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country. Additional information on this study and the drug concerned may be provided upon request based on Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of Boehringer Ingelheim. V1.0/2014

2 Trial Code: MEN-SES-1 Page 3 of SYNOPSIS Title of study: Investigator(s): Study centre(s): Publication (reference): Clinical phase: A prospective, open label, multicentre study to investigate the endometrial safety of during 52 weeks of administration in post-menopausal women suffering from symptoms related to estrogen deficiency. Study of clinical phase IV carried out in private practices (gynaecologists) or in outpatient clinics Multi-centre study; 44 study centres in the Czech Republic and Poland not applicable IV Objectives: Objective of the trial was to provide a sufficiently precise estimate of the rate of endometrial hyperplasia and more severe adverse endometrial outcome and to establish the safety, tolerability, and efficacy of a 52-week peroral treatment with in a large number of postmenopausal women. Methodology: Open label, non-comparative, prospective, multicentre, multinational study with a 1 to 4-week run-in / screening phase to confirm eligibility of the patients No. of subjects entered: planned: 300 evaluable patients screened: 686 patients enrolled: 400 patients Diagnosis and main criteria for inclusion: Test product: Ambulatory female patients, between 50 and 75 years of age, with the last spontaneous menstrual period 2 years ago, suffering from symptoms of estrogen deficiency (estradiol-17ß <40 pg/ml, FSH 35mU/mL), with a minimum number of 7 moderate to severe hot flushes per week prior to screening and baseline visit, intact uterus, and a histologically proven, non-pathological endometrium. Menofem FCT (Cimicifuga racemosa rhizoma extract) - dose: dry extract from Cimicifuga racemosa rhizoma, corresponding to 20 mg of the crude drug, twice daily (one film-coated tablet contained mg of native dry extract) - mode of admin.: peroral, in the morning and evening - batch no.: Duration of treatment: Reference therapy: 52 weeks n.a.

3 Trial Code: MEN-SES-1 Page 4 of 117 Criteria for evaluation: Safety: Primary endpoint: Rate of endometrial hyperplasia and more serious adverse endometrial outcome (carcinoma) according to categories of the classification of the CPMP guideline»points to consider on Hormone Replacement Therapy«(1997) modified according to Kurman and Mazur (1987) after continuous application of the investigational product for 52 weeks. An adverse outcome includes the following categories: 5-3 Endometrium with polyps (polyps with proliferative/hyperplastic features); 6-1 Simple hyperplastic endometrium (glands with only architectural abnormalities, including a disordered proliferative pattern and cystic glandular hyperplasia); 6-2 Complex hyperplastic endometrium (crowded, architecturally abnormal glands without cytologic atypia); 6-3 Atypical hyperplastic endometrium (glands with both cytological and architectural abnormalities); 7 Carcinoma; 8-1 Others (types of hyperplasia or neoplasm not mentioned in categories 5-3, 6 or 7). Secondary endpoints: - Incidence and degree of an increase in endometrial thickness; - Incidence and intensity of vaginal bleeding; - Incidence of serious adverse events (SAE), adverse events (AE) and of (serious) adverse drug reactions ((S)ADR); - Changes in laboratory safety parameters with respect to baseline and reference ranges; - Changes in the gynaecological status by assessment of the cervical smear, examination of the breasts, or mammography if required. Efficacy: - Changes in the incidence and intensity of hot flushes (Diary); - Changes in the intensity of menopausal symptoms according to the Menopause Rating Scale II (MRS II) (Potthoff et al., 2000); - Changes in major menopausal complaints by means of items 1, 4, 10, 11 of the MRS II; - Changes in FSH, LH, and E2 serum concentrations; - Changes in the degree of maturity of the vaginal epithelium; - Changes in the concentration of bone formation markers (bone ALP, Osteocalcin) and bone degradation markers (CrossLaps); - Changes in lipometabolism (total cholesterol, HDL, LDL, triglycerides); - Global assessment of efficacy given by the patient after 26 and 52 weeks of treatment.

4 Trial Code: MEN-SES-1 Page 5 of 117 Statistical methods: Descriptive statistics incl. mean and standard deviation, median and range were used for analysis of continuous parameters. Frequency distributions were calculated for nominal or ordinal data. In view of the primary variable, the main population for analysis was considered to be protocol compliant completers (PCC) population. Point estimators and the respective upper limit of the 95% confidence interval were calculated for the probability of endometrial hyperplasia or more serious adverse endometrial outcome. SUMMARY CONCLUSIONS: Patients and disposition A total of 686 patients were screened of whom 400 patients (58.3%) were enrolled, received at least one dose of the study medication, and thus represented the safety and ITT populations. Twenty-five patients (6.3%) were prematurely discontinued. The remaining 375 patients (93.7%) completed the 52-week treatment period. As no major protocol deviations were identified upon the final data review, none of these patients was excluded from the protocol compliant completers (PCC) population. With one exception, an endometrial biopsy was taken in all of them after the end of treatment (374 patients, 99.7%). In 335 of these patients (89.6%) the biopsy was evaluable, while this was not the case in 39 patients (10.4%) because no or insufficient endometrial tissue was available or because the interval between the first unsuccessful bioptic sampling at trial end and the successful repeat procedure exceeded 42 days. All patients were females, 49 to 75 years of age (mean age: 56.5 years) with an average body height of cm), a mean body weight of 68.2 kg, an average BMI of 24.7 kg/m 2, and an average body fat ratio of 30.0%. Their last menses had occurred 18 months to 28 years ago (median: 51 months). At the beginning of treatment all women suffered from symptoms related to estrogen deficiency and experienced at least seven moderate to severe hot flushes per week. Moreover, the serum oestradiol-17ß concentration upon screening ranged from 5.0 to 39.4 pg/ml (mean value: 20.4 pg/ml), and the FSH concentration from 28.9 to mu/ml (mean value: 74.7 mu/ml). The endometrial thickness as measured by endovaginal sonography was 5 mm (range: 0.3 to 5.0 mm). Treatment compliance based on tablet counts upon each of the study visits was very high and on average amounted to 99.7 ± 3.3% (range: 78.5% to 125.3%). Safety Overall, a daily dose of two tablets (corresponding to 20 mg of the crude drug twice daily) for 52 weeks was well tolerated in this population of postmenopausal women. A total of 335 patients of the PCC population were included in the analysis of the primary variable, i.e. the rate of endometrial hyperplasia or more serious endometrial outcome. In none of these patients, an adverse safety endpoint as defined in paragraph of the study protocol (biopsy results 5-3, 6, 7 or 8-1) was reached. Based on these results, the point estimator for the primary response variable was calculated to be 0.0 with an upper limit of the 95% confidence interval of (1.1%). Safety-relevant information (including endovaginal sonography) on premature withdrawals as well as patients of the PCC population without an evaluable end-of-trial biopsy showed no hints of an adverse treatment effect on the endometrium.

5 Trial Code: MEN-SES-1 Page 6 of 117 Based on average values, no noteworthy increase in endometrial thickness as estimated by transvaginal ultrasound was observed, neither for the PCC population nor the subpopulations analysed. Technical quality of cervical Pap smears was satisfactory in the majority of PCC patients after 26 weeks (n=319, 85.1%) and 52 weeks of treatment (n=339, 90.4%). Upon visit 5, four patients (1.3%) had abnormal results (mainly signs of inflammation or infection). In two of these patients epithelial cell abnormalities of mild intensity were diagnosed. The vast majority of patients reporting vaginal bleeding had 2 bleeding episodes (n=42 of 54, 77.8%); moreover, most of them reported mild bleeding (n=7, 13.0%) or spotting only (n=33, 61.1%). Mammographies were performed at trial end in 318 of the 375 patients of the PCC population (84.8%), and normal results were reported for 297 of them (93.4%). Twenty-one patients had signs of irregularities, mainly (fibrous) mastopathy without signs of malignancy. These cases included one patient diagnosed with invasive ductal carcinoma without metastasis; this event was considered to have had no causal relationship with the investigational compound. No deaths occurred. None of the 8 non-lethal serious adverse events (including one case of breast cancer) was considered to have had a causal relationship with study treatment or led to premature discontinuation of study treatment. The number of non-serious AEs was quite important as a total of 752 АЕs were reported in 289 out of the 400 patients. However, the overwhelming majority of AEs (659 out of 752, 87.6%) were of mild intensity, and more than half of them (n=414, 55.1%) in the assessment of the investigator were unrelated to intake of the study medication. More than half of all adverse events and the vast majority of those for which a causal relationship with the investigational treatment was assumed, were related to changes in lipid metabolism. Independent of his/her judgement of clinical relevance, the investigator had to report as an AE all lipid results exceeding predefined threshold values. Moreover, in case of mixed lipid abnormalities this had to be done separately for total cholesterol, LDL-cholesterol and serum triglycerides, thus unreasonably increasing the number of events. Relevant bias was also introduced by the fact that though this was not a formal exclusion criterion in the study protocol normal lipid values were required in patients in order to be eligible for enrolment. While upon the screening examination repeat examinations of total cholesterol, LDL-cholesterol and serum triglycerides were performed in a relevant number of patients with deviating results, this was no more the case during later study visits and at trial end when the first measured value was reported as such. Markedly fluctuating results in individual patients point towards the fact that samples may not have consistently been taken in fasted condition. Analysis of average course of lipid values and calculation of individual LDL/HDL cholesterol ratios suggest that 52-week treatment with the investigational compound did not have a negative impact on parameters of lipid metabolism. No untoward effects of treatment with were detectable upon analysis of other parameters of laboratory safety or vital signs. Efficacy At treatment start, all patients enrolled had sufficiently expressed vasomotor symptoms, i.e. at least seven moderate to severe hot flushes per week. Over the 52-week treatment period, there was a marked and continuous improvement in the patients symptomatology as demonstrated by a 85% decrease in the 2-weekly weighted sum score of hot flushes from a median of 9.1 during the run-in period to 1.4 at the end of the treatment period. In parallel relevant improvements were also seen in the frequency of sleeping disorders, i.e. the proportion of nights when the patient had difficulties falling asleep or woke up early or the frequency of awakenings per night.

6 Trial Code: MEN-SES-1 Page 7 of 117 The Menopause Rating Scale II (MRS II) was used as a standardised tool to assess the severity of 11 different neurovegetative, psychic or genital symptoms of postmenopausal estrogen deficiency. Upon screening, symptoms were moderately expressed; the average total MRS II score amounted to 13.8 ± 7.5 and thus was about 30% of the maximum achievable score value. By the end of treatment, the score had almost halved and on average was 6.8 ± 6.3. An almost parallel decrease was observed for the sum score based on 4 major climacteric complaints included in the MRS II (hot flushes, depressive mood, dryness of vagina, joint and muscular discomfort). Thus, the results demonstrate that patients enrolled in this clinical trial experienced a relevant improvement in their subjective climacteric complaints. In view of the lack of a placebo control group, it is difficult to quantify medication-related effect. Hormone analyses demonstrated that endocrine effects of the investigational compound were comparably weak. There was a weak trend towards slightly lower FSH and LH levels during the 52-week study period. Due to a number of outliers (most probably due to the presence of ovulatory/unovulatory cycles in these patients) and the skewed distribution of values median results are considered a better measure of central tendency. Based on median estrogen values there was a decrease in the concentration of this hormone as well. In parallel, the percentage of women with plasma estrogen levels below the lower limit of quantitation increased from 4.0% (n=15) upon screening to 24.0% (n=90) at the end of the study. On the other hand, there was a clear change in vaginal cytology : the percentages of superficial and parabasal cell types were statistically significantly increased at study end, while that of intermediary cells had decreased during the 52-week period. Compared with screening, the plasma levels of markers specific for bone formation (osteocalcin, bonespecific alkaline phosphatase) and osteoclastic activity (β-crosslaps) were more or less unchanged at the end of treatment with the investigational compound. Based on average values, parameters of lipid metabolism did hardly change over the treatment period. There was tendency towards a rise in serum triglycerides and also albeit to a lesser extent in total serum cholesterol; at least partially, the latter change was due to a minor increase in HDL cholesterol. Relevant bias was introduced by the fact that upon screening repeat analyses were made in case of critically high results whereas this was no more the case after start of active treatment. In addition, markedly fluctuating lipid values point to the fact that during the 52-week treatment period blood samples were not strictly taken under fasted conditions. Overall, the treatment did not relevantly influence any of the parameters used to assess potential effects of the treatment on skin and its appendages. At trial end more than 90% of patients favourably rated the overall efficacy of the treatment, and only two patients reported a worsening of their condition. In about half of the patients having given a favourable overall assessment, the improvement was considered major, while the other half did at least fairly better.

7 Trial Code: MEN-SES-1 Page 8 of 117 Conclusions This study produced no hint that daily treatment of postmenopausal women with for 52 weeks resulted in endometrial risk. Overall, the investigational treatment was well tolerated. As compared with previous studies, this trial did not provide evidence of any unexpected or new findings with regard to its safety and tolerability. Postmenopausal women enrolled in this clinical trial experienced a relevant improvement in their subjective climacteric complaints. As the primary objective was to obtain endometrial safety data, the trial was not designed for a confirmatory assessment of treatment efficacy. Therefore, in view of the lack of a placebo control group, it is difficult to quantify the medication-related effect.

Individual Study Table Referring to Part of the Dossier. Volume: Page:

Individual Study Table Referring to Part of the Dossier. Volume: Page: 1 SYNOPSIS (CR002878) Title of Study: The effect of on vasomotor symptoms in healthy postmenopausal women: a double-blind placebo controlled pilot study Investigators: Multiple, see Section 4, Investigators

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Estetrol, the Next Generation of Hormone Therapy: Results of a Phase 2b Dose-finding Study in Postmenopausal Women (E4 Relief)

Estetrol, the Next Generation of Hormone Therapy: Results of a Phase 2b Dose-finding Study in Postmenopausal Women (E4 Relief) Estetrol, the Next Generation of Hormone Therapy: Results of a Phase 2b Dose-finding Study in Postmenopausal Women (E4 Relief) Prof Wulf H Utian Case Western Reserve University School of Medicine, Cleveland,

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Disclosures. REPLENISH Trial: Objective and Design. Background Use of compounded bioidentical hormone therapy (CBHT) has become highly prevalent

Disclosures. REPLENISH Trial: Objective and Design. Background Use of compounded bioidentical hormone therapy (CBHT) has become highly prevalent 17β Estradiol/Progesterone in a Single Oral Softgel Capsule (TX 001HR) Significantly Reduced Moderate to Severe Vasomotor Symptoms without Endometrial Hyperplasia Disclosures Research support: Actavis,

More information

Columbia University Medical Center, New York, NY 2. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 3

Columbia University Medical Center, New York, NY 2. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 3 17β-Estradiol/Progesterone in a Single Oral Softgel Capsule (TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor Symptoms without Endometrial Hyperplasia Rogerio A Lobo, MD 1 ; David F Archer,

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: This drug is not marketed in the United States.

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: This drug is not marketed in the United States. PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Summary CHAPTER 1. Introduction

Summary CHAPTER 1. Introduction Summary This thesis aims to evaluate the diagnostic work-up in postmenopausal women presenting with abnormal vaginal bleeding. The Society of Dutch Obstetrics and Gynaecology composed a guideline, which

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

bleeding Studies naar de diagnostiek van endom triumcarcinoom bij vrouwen met postm nopauzaal bloedverlies. Studies on the

bleeding Studies naar de diagnostiek van endom triumcarcinoom bij vrouwen met postm nopauzaal bloedverlies. Studies on the Studies on the diagnosis of endometria cancer in women with postmenopausal bleeding. Studies naar de diagnostiek va endometriumcarcinoom bij vrouwen m postmenopauzaal bloedverlies. Studies on the diagnosis

More information

SYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only)

SYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only) SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20 mg) multicenter study of long-term glycemic control with rimonabant in treatment-naïve

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Trial Results Database Page 1

Clinical Trial Results Database Page 1 Page 1 Sponsor Novartis UK Limited Generic Drug Name Letrozole/FEM345 Therapeutic Area of Trial Localized ER and/or PgR receptor positive breast cancer Study Number CFEM345EGB07 Protocol Title This study

More information

Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms

Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms Photo (compulsory) Steven R Goldstein, MD 1 ; Ginger D Constantine, MD 2 ; David F Archer, MD 3 ; James H Pickar,

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Imvexxy (estradiol) NEW PRODUCT SLIDESHOW

Imvexxy (estradiol) NEW PRODUCT SLIDESHOW Imvexxy (estradiol) NEW PRODUCT SLIDESHOW Introduction Brand name: Imvexxy Generic name: Estradiol Pharmacological class: Estrogen Strength and Formulation: 4mcg, 10mcg; vaginal inserts Manufacturer: TherapeuticsMD,

More information

Clinical Trial Study Synopsis

Clinical Trial Study Synopsis Clinical Trial Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Abnormal Uterine Bleeding. Richard Dover Specialist gynaecologist

Abnormal Uterine Bleeding. Richard Dover Specialist gynaecologist Abnormal Uterine Bleeding Richard Dover Specialist gynaecologist A pragmatic guide. Wide topic range What s not coming up Precocious puberty Menorrhagia well maybe just a little Topics Adolescents IMB

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Date: 24 April-2007 Trial ID: GHTUR/E/2 Version: 2 Integrated Clinical Trial Report Status: Final ICTR Synopsis Page: 1 of 5

Date: 24 April-2007 Trial ID: GHTUR/E/2 Version: 2 Integrated Clinical Trial Report Status: Final ICTR Synopsis Page: 1 of 5 ICTR Synopsis Page: 1 of 5 Synopsis TITLE OF TRIAL INDUCTION OF PUBERTY WITH 17 Β-ESTRADIOL IN GIRLS WITH TURNER SYNDROME. AN OPEN RANDOMISED TRIAL TRIAL CODE: GHTUR/E/2 INVESTIGATORS IN TOTAL, 35 PRINCIPAL

More information

Endometrial line thickness in different conditions.

Endometrial line thickness in different conditions. Endometrial line thickness in different conditions 1 Endometrial thickens in response to Rising estrogen levels during the menstrual cycle and then shedding endometrial at the times of menses 2 The thickens

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

BRL /RSD-101C0F/1/CPMS-716. Report Synopsis

BRL /RSD-101C0F/1/CPMS-716. Report Synopsis Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-Term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-004HR) in Menopausal Women with Moderate to Severe Dyspareunia

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-004HR) in Menopausal Women with Moderate to Severe Dyspareunia Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-4HR) in Menopausal Women with Moderate to Severe Dyspareunia Lisa Larkin, MD 1 ; Andrew M Kaunitz, MD 2 ; James Liu, MD

More information

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779)

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779) TITLE OF THE STUDY / REPORT No. / DATE OF REPORT INVESTIGATORS / CENTERS AND COUNTRIES Clinical Study Report Protocol BC20779: Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Study Code: Date: 27 July 2007

Study Code: Date: 27 July 2007 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:

More information

Clinical Trial Study Synopsis

Clinical Trial Study Synopsis Clinical Trial Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website and is provided for patients and healthcare professionals to increase the transparency

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Correlation of Endometrial Thickness with the Histopathological Pattern of Endometrium in Postmenopausal Bleeding

Correlation of Endometrial Thickness with the Histopathological Pattern of Endometrium in Postmenopausal Bleeding DOI 10.1007/s13224-014-0627-z ORIGINAL ARTICLE Correlation of Endometrial Thickness with the Histopathological Pattern of Endometrium in Postmenopausal Bleeding Singh Pushpa Dwivedi Pooja Mendiratta Shweta

More information

PERIMENOPAUSE. Objectives. Disclosure. The Perimenopause Perimenopause Menopause. Definitions of Menopausal Transition: STRAW.

PERIMENOPAUSE. Objectives. Disclosure. The Perimenopause Perimenopause Menopause. Definitions of Menopausal Transition: STRAW. PERIMENOPAUSE Patricia J. Sulak, MD Founder, Living WELL Aware LLC Author, Should I Fire My Doctor? Author, Living WELL Aware: Eleven Essential Elements to Health and Happiness Endowed Professor Texas

More information

EVALUATION OF THE CERVICO-VAGINAL CYTOLOGY SMEARS IN POSTMENOPAUSAL WOMEN

EVALUATION OF THE CERVICO-VAGINAL CYTOLOGY SMEARS IN POSTMENOPAUSAL WOMEN EVALUATION OF THE CERVICO-VAGINAL CYTOLOGY SMEARS IN POSTMENOPAUSAL WOMEN C. Ülgüt, L. Păiuşan, P. Deme Abstract. Hormone-related cancers account for almost 30% of all cancer cases. Thanks to the continuous

More information

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

The 6 th Scientific Meeting of the Asia Pacific Menopause Federation

The 6 th Scientific Meeting of the Asia Pacific Menopause Federation Abnormal uterine bleeding in the perimenopause Perimenopausal menstrual problems are among the most common causes for family practitioner and specialist referral. Often it is due to the hormone changes

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Hormones friend or foe? Undertreatment and quality of life. No conflicts of interest to declare

Hormones friend or foe? Undertreatment and quality of life. No conflicts of interest to declare Hormones friend or foe? Undertreatment and quality of life Anette Tønnes Pedersen MD, Ph.D. Consultant, Associate professor Dept. Of Gynecology / Fertility Clinic Rigshospitalet No conflicts of interest

More information

Orals,Transdermals, and Other Estrogens in the Perimenopause

Orals,Transdermals, and Other Estrogens in the Perimenopause Orals,Transdermals, and Other Estrogens in the Perimenopause Cases Denise Black, MD, FRCSC Assistant Professor, Obstetrics, Gynecology and Reproductive Sciences University of Manitoba 6/4/18 197 Faculty/Presenter

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Summary of the risk management plan (RMP) for Senshio (ospemifene)

Summary of the risk management plan (RMP) for Senshio (ospemifene) EMA/736568/2014 Summary of the risk management plan (RMP) for Senshio (ospemifene) This is a summary of the risk management plan (RMP) for Senshio, which details the measures to be taken in order to ensure

More information

BRL /RSD-101C0D/1/CPMS-704. Report Synopsis

BRL /RSD-101C0D/1/CPMS-704. Report Synopsis Report Synopsis Study Title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo- Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with

More information

Protocol Number: BV-2005/01. OM Pharma OM-85

Protocol Number: BV-2005/01. OM Pharma OM-85 Page 3 SYNOPSIS Protocol Number: Name of Finished Product: Broncho-Vaxom (Broncho-Munal ) Title: Double-Blind, Placebo-Controlled, Randomised Clinical Study of Broncho-Vaxom in Children Suffering from

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

SYNOPSIS. Clinical Study Report CN138002: Addendum 1. Individual Study Table Referring to the Dossier

SYNOPSIS. Clinical Study Report CN138002: Addendum 1. Individual Study Table Referring to the Dossier Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abilify Name of Active Ingredient: aripiprazole Individual Study Table Referring to the Dossier (For National Authority Use Only)

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Endometrial Cancer Biopsy of the endometrium Evaluation of women of all ages

Endometrial Cancer Biopsy of the endometrium Evaluation of women of all ages Endometrial Cancer Biopsy of the endometrium Evaluation of women of all ages Barbara S. Apgar, MD, MS Professor of Family Medicine University of Michigan Health System Ann Arbor, Michigan Cancer of the

More information

Clinical Trial Synopsis

Clinical Trial Synopsis Clinical Trial Synopsis Title of Study: A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long-Term Administration of TAK-375 in Subjects With Chronic Insomnia Protocol Number: Name

More information

SYNOPSIS. Co-ordinating investigator Not applicable. Study centre(s) This study was conducted in Japan (57 centres).

SYNOPSIS. Co-ordinating investigator Not applicable. Study centre(s) This study was conducted in Japan (57 centres). Drug product: Symbicort Turbuhaler Drug substance(s): ST (Symbicort Turbuhaler ) Edition No.: 1.0 Study code: D5890C00010 Date: 15 March 2007 SYNOPSIS An 8-week, randomised, double blind, parallel-group,

More information

Learning Objectives. Peri menopause. Menopause Overview. Recommendation grading categories

Learning Objectives. Peri menopause. Menopause Overview. Recommendation grading categories Learning Objectives Identify common symptoms of the menopause transition Understand the risks and benefits of hormone replacement therapy (HRT) Be able to choose an appropriate hormone replacement regimen

More information

Fraser IS, 1 Parke S, 2 Mellinger U, 2 Machlitt A, 2 Jensen JT 4

Fraser IS, 1 Parke S, 2 Mellinger U, 2 Machlitt A, 2 Jensen JT 4 An oral contraceptive comprising oestradiol valerate/dienogest is effective in the treatment of heavy and/or prolonged menstrual bleeding: a pooled analysis Fraser IS, 1 Parke S, 2 Mellinger U, 2 Machlitt

More information

Frequency of menses. Duration of menses 3 days to 7 days. Flow/amount of menses Average blood loss with menstruation is 60-80cc.

Frequency of menses. Duration of menses 3 days to 7 days. Flow/amount of menses Average blood loss with menstruation is 60-80cc. Frequency of menses 24 days (0.5%) to 35 days (0.9%) Age 25, 40% are between 25 and 28 days Age 25-35, 60% are between 25 and 28 days Teens and women over 40 s cycles may be longer apart Duration of menses

More information

Protocol GTC : A Randomized, Open Label, Parallel Design Study of Sevelamer Hydrochloride (Renagel ) in Chronic Kidney Disease Patients.

Protocol GTC : A Randomized, Open Label, Parallel Design Study of Sevelamer Hydrochloride (Renagel ) in Chronic Kidney Disease Patients. Protocol GTC-68-208: A Randomized, Open Label, Parallel Design Study of Sevelamer Hydrochloride (Renagel ) in Chronic Kidney Disease Patients. These results are supplied for informational purposes only.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Chapter 10: Pap Test Results

Chapter 10: Pap Test Results Chapter 10: Pap Test Results On completion of this section, the learner will be able to: 1. Identify how Pap test results are interpreted and the reasons for normal and abnormal results. 2. Describe the

More information

Personal Data. Present Symptoms

Personal Data. Present Symptoms Chris A. Pate, MD 2280 Hwy 70 West, Suite B 265 Racine Drive, Suite 102 Goldsboro, NC 27530 Wilmington, NC 28403 (919) 988-9332 Fx(919) 581-0353 (910) 399-6661 Fx(910) 399-6667 Name Personal Data Address

More information

SYNOPSIS. Study Coordinator. Study centre(s)

SYNOPSIS. Study Coordinator. Study centre(s) Drug product: Seroquel Drug substance(s): Quetiapine Document No.: 1 Edition No.: 1 Study code: D1449C00005 Date: 02 January 2007 SYNOPSIS A Randomized, Parallel Group, Open Trial Examining the Safety,

More information

4. Other Data Relevant to an Evaluation of Carcinogenicity and its Mechanisms

4. Other Data Relevant to an Evaluation of Carcinogenicity and its Mechanisms 550 4. Other Data Relevant to an Evaluation of Carcinogenicity and its Mechanisms 4.1 Absorption, distribution, metabolism and excretion 4.1.1 Humans The pharmacokinetics of the newer progestogens, desogestrel,

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI) PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

10/07/18. Conflict of interest statement

10/07/18. Conflict of interest statement Care: principles, best practices in Europe and how reproductive/sexual health care providers might contribute Petra De Sutter University Hospital Gent Conflict of interest statement My department occasionally

More information