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Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer Healthcare AG Study Number: 504 NCT00000000 Study Phase: N/A Official Study Title: Activity and tolerability of BAY B 5097 10% vaginal cream in patients with vaginal Candida infections (open, mycologically controlled study). Therapeutic Area: Anti-Infectives Test Product Name of Test Product: Canesten (Clotrimazole, BAY B 5097) 10% vaginal cream Name of Active Ingredient: Dose and Mode of Administration: bis-phenyl-(2-chlorophenyl)-1-imidazolyl-methane (Clotrimazole) Single intravaginal dose of about 5.0 g of cream (500 mg of the active substance), administed by the doctor with the aid of an applicator. Reference Therapy/Placebo Reference Therapy: Not applicable Dose and Mode of Administration: Not applicable Duration of Treatment: Duration of treatment was one day. Studied period: Date of first subjects first visit: January 1982 Date of last subjects last visit: May 1982 Study Center(s): The study was conducted at single center in Germany Page 1 of 4
Methodology: The material for the detection of pathogens by culture was collected by a vaginal smear. Detection of pathogens by culture constituted the main criterion for including the subject in the study. If a positive native preparation was not confirmed by mycological culture, the subject was excluded from the rest of the study and evaluated only in respect to local tolerability. Before the start of treatment, the severity of the infection was classified into one of three grades on the basis of the clinical symptoms: "Slight": colposcopy revealed no visible alteration of the vaginal mucosa "Moderate": colposcopy revealed visible alteration of the vaginal mucosa "Severe": macroscopically visible alteration of the vaginal mucosa. The therapeutic results were checked on the basis of mycological (native preparation and culture) and clinical findings, one and four weeks after the end of therapy. The final evaluation of the clinical outcome was based on the following criteria: normalization (cure) was assumed when objectively discernible, individual symptoms were no longer present and the subject was not suffering from any subjective complaints. In the case of subjects with clinical symptoms and positive mycological findings at the first check-up, the doctor conducting the therapy was free to initiate a substitute therapy. Such cases were classified as "failures" and were included in the evaluation as such. At the first follow-up, the subjects were asked to state the day after the treatment on which the subjective complaints were eliminated. At the first check-up, the subjects were asked about the acceptability and local tolerability of the cream. Any local intolerance was recorded. Indication/ Test Indication: Main Inclusion Criteria: Vaginal yeast infection. Inclusion criteria: Clinical findings of a vaginal yeast infection. Mycological findings: o Positive native preparation with detection of pseudomycelia o Confirmation by the detection of pathogens in the culture. Study Objectives: Overall: To investigate the therapeutic activity and tolerability of BAY B 5097 10% vaginal cream in subjects with vaginal yeast infections, within the framework of an open, mycologically controlled study. Primary: To demonstrate therapeutic activity and local tolerability of the test product. Page 2 of 4
Evaluation Criteria: Efficacy (Primary): One and four weeks after the end of the therapy, the therapeutic results were checked on the basis of mycological (native preparation and culture) and clinical findings of a vaginal yeast infection. Safety: Tolerance by the subjects to the study drug application Statistical Methods: Efficacy (Primary): The results of the mycological and clinical tests were presented in the form of multi-field tables. The evaluation was carried out with routines of the BMDP program package (univariate description) and the SAS program package. Safety: Data regarding tolerability of the drug was collected. Number of Subjects: The study was planned to include 30 subjects. Forty subjects were enrolled and 34 were evaluated. Five subjects were not evaluated as they did not meet inclusion criteria, and one subject did not attend follow-up examinations. Study Results Results Summary Subject Disposition and Baseline The 34 subjects included in the evaluation were between 16 and 52 years old (median age 26 years), weighed 49 to 104 kg (median weight 60 kg), and were 159 to 172 cm tall (median height 167 cm). In 18 subjects, the anamnestic investigation revealed a primary infection and in 16 subjects, a recurrent vaginal yeast infection. On the basis of the clinical picture there were four subjects with of a "slight" form of infection, 18 subjects with a "moderate" form of infection and 12 subjects with a "severe" form of infection. In the majority of the subjects, the infection had been present for up to one week. Candida albicans was identified as the causative organism in 26 subjects (76%), Torulopsis glabrata in 5 subjects (15%), and Candida krusei in one subject. In two subjects, it was not possible to identify the Candida species. Results Summary Efficacy At the first follow-up examination with data on 32 subjects, the culture findings were negative in 24 subjects (75%). At the time of the second follow-up, culture findings were negative in 21 of the 27 subjects (78%). The native preparation results indicated 31 of 34 subjects (91%) gave negative native smear findings at the first follow-up exam. Three of these were positive at the second exam. Of the three subjects with positive native findings at the first exam, one was negative at the second exam, one remained positive, and there was no exam for the third. Page 3 of 4
The clinical symptoms in the majority of subjects were eliminated by the treatment. Twelve subjects (36%) reported improvement on the first day, 13 subjects (39%) on the second day, seven subjects (21%) on the third day and one subject on the fourth day after treatment. There was no information regarding this evaluation for one subject. Twenty-nine subjects complained of itching before the treatment. This symptom was eliminated in 26 (90%) of the subjects. Twenty-three subjects reported burning before the start of the treatment. Twenty-one of these (91%) no longer reported burning at the first check-up. Thrush patches were detected in 20 subjects before the start of the therapy. These were eliminated in all 20 subjects at the time of the first check-up. At the first follow-up exam, the concomitant vulvitis that had been diagnosed in 25 subjects before the therapy was eliminated. Before the start of the treatment 32 subjects exhibited a pathological alteration of the vaginal skin. At the first check-up, the redness observed in 24 subjects had been eliminated. Thirty-one out of 34 subjects (91%) were "successfully treated" at the first check-up; three of them relapsed at the second check-up. Of the three subjects assessed as treated without success at the first follow-up exam, two were later evaluated as successfully treated; in the third subject, no investigation was performed. In all, five subjects did not undergo a second check-up. Of the total of 29 subjects for whom a clinical evaluation of the treatment was made at the second follow-up exam, 26 were "successfully treated" Results Summary Safety Side effects were recorded in three of the 34 subjects. There were two cases of "burning" and one for which no specific details were available. No side effects were recorded in the five subjects who were eliminated from the overall evaluation. Conclusion(s) On the basis of the results of this study, BAY B 5097 10% vaginal cream single dose therapy was effective in treating vaginal yeast infections. In this study, the subjects tolerated BAY B 5097 10% vaginal cream. Publication(s): Not applicable Date Created or Date Last Updated: 18 Aug 2011 Page 4 of 4