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1 Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct :37:40 GMT) CTRI Nuber Last Modified On 13/10/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/11/ [Registered on: 04/11/2016] - Trial Registered Prospectively No Interventional Drug Randoized, Parallel Group, Multiple Ar Trial To study efficacy and safety of Progesterone SR tablets in patient with secondary aenorrhea An Open label, Randoized, Multicentric, Parallel group, 4 ar, coparartive phase III study to evaluate the Efficacy and Safety of Progesterone SR oral tablets versus Progesterone oral tablets in woen with secondary aenorrhea associated with noral estrogen levels. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) synoke/ct-iii/proges/ ,v1.2, Dated Protocol Nuber Details of Principal Investigator Eail Details Contact Person (Scientific Query) Eail Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Eail Source of Monetary or Material Support > Synoke Pharaceuticals Liited, Synoke House, 14/486, Outer Ring road, Block 12, Sunder Vihar,Paschi Vihar, New Delhi Type of Sponsor NIL List of Countries of Principal Investigator Priary Sponsor Details Synoke Pharaceuticals Ltd Synoke House, 114/486, Sunder nagar, Outer Ring Road, Pachi Vihar, New Delhi-87 Pharaceutical industry-n NIL of Site Site Phone//Eail Dr Sarita Agrawal AIIMS No:3117 Depatent of Gyanecology and Obstetrics All Institute of Medical Sciences Tatibandh GE Road Raipur Raipur CHHATTISGARH Dr Malay Krishna Bari MBBS MD Gynaecology District Dr MoushiB Governent Medical Parpillewar MBBS DGO College and DNB Dr Anjali soni Dr Sabhunath Bandyopadhyay MBBS DGO MS GO Dr Anita Bansal MBBS MS Gujarat edical education and Research Society Medical college and Genenal IPGME&R/SSKM Maharaja Agrasen District, Howrah, 10No. Biplobi Haren Ghosh Sarani, Howrah Haora WEST BENGAL Governent Medical College and, Medical College square, Nagpur , Maharashtra, Nagpur MAHARASHTRA Departent OBG GEMRS Medical College and Gotri ain road Vadodara Vadodara GUJARAT IPGME&R/SSKM, Departent of Obstetrics and Gynaecology, 244 J.C Bose Road, Kolkata , West Bengal, Kolkata WEST BENGAL Maharaja Agrasen, West Punjabi drsaritaagrawal@yahoo.co alaykrishna@gail.co oushibbs@yahoo. co anjalisoni@gail.co su_dip2005@yahoo.co page 2 / 5

3 Details of Ethics Coittee Dr Sulabha Joshi MBBS MD Dr T Sasikala MBBS MD OBG N.K.P Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Rajiv Gandhi Institute of RIMSGGH Bagh, New Delhi-l West DELHI N.K.P Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Digdoha Hills, Hingana Road, Nagpur Nagpur MAHARASHTRA Rajiv Gandhi Institute of RIMSGGH, Srikakula, , AP, Srikakula ANDHRA PRADESH anandds@gail.co sulabhaajoshi@gail.c o sasikalabbs@gail.c o of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? District Coittee-Howrah Institute Ethics Coittee, AIIMS, Raipur Chhattisgarh Coittee Departent of Pharacology Governent Medical College and, Nagpur- Coittee N.K.P Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Coittee R. No, 614, 6th Floor Maharaja Agrasen, West Punjabi Bagh, New Delhi- Coittee, Rajiv Gandhi Institute of RIMSGGH, Institutional Huan Ethics ( Institutional Review Board) Gotri Road, Vadodara IPGME&R Research Oversight Coittee Approved 14/09/2016 No Not Applicable No Date Specified No Approved 08/12/2016 No Approved 31/08/2016 No Approved 15/09/2016 No Approved 16/02/2017 No Approved 20/03/2017 No Approved 03/09/2016 No Regulatory Clearance Status Date page 3 / 5

4 Status fro DCGI Approved/Obtained 29/09/2015 Health Condition / Probles Studied Intervention / Coparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Rando Sequence Method of Concealent Blinding/Masking Health Type Patients Condition Woen with secondary aenorrhea associated with noral estrogen levels Type Details Intervention Progesterone 200g SR tablets Progesterone 300g SR tablets Progesterone 400g SR tablets 200 g/300 g/400 g, orally Taken once a day at bed tie 10 days a onth Coparator Agent Progesterone 400 g tablets one tablet 400 g taken orally at bed tie 10 days a onth Age Fro Age To Gender Details Details Year(s) Year(s) Feale Coputer generated randoization An Open list of rando nubers Open Label Inclusion Criteria 1.Non hysterectoized woen of the age of 25 to 45 years. 2.Woen whose enstrual cycles disappear for 6 consecutive onths with irregular enses or for 3 consecutive onths with regular enses 3.Woen willing to give infored consent Exclusion Criteria 1.Woen with hypersensitivity to any of the test or control forulation drugs or their excipients 2.Pregnant or nursing woen 3.Woen of childbearing potential not using edically approved eans of contraception 4.History of drug or alcohol abuse 5.Woen who are in enopause phase 6.Woen with undiagnosed irregular vaginal bleeding 7.Those with any edical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy will be excluded fro the study 8.Woen with alignancy (uterine breast) or with faily history of alignancy 9.Woen with gall stone disease 10.Woen with DVT or history of CVD 11.Woen with thyroid disease 12.Woen with ovarian failure 13.Woen with Asherans Syndroe Priary Outcoe Outcoe Tiepoints 1.Inducing withdrawal bleeding 2.aintaining regular bleeding, in woen with secondary aenorrhea At day 0 At day 30 At day 60 At day 90 Secondary Outcoe Outcoe Tiepoints Target Saple Size 1.Tolerability 2.Changes in bleeding pattern post treatent as copared to baseline Total Saple Size=388 At day 0 At day 30 At day 60 At day 90 page 4 / 5

5 Powered by TCPDF ( PDF of Trial Phase of Trial Phase 3 Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary Saple Size fro =388 08/11/2016 No Date Specified Years=0 Months=7 Days=0 Not Applicable Copleted PROGESTERONE tablets contain icronized progesterone for oral adinistration. This copound overcoes probles with absorption through the gut associated with exogenous progesterone adinistration so that it can be used orally to achieve required seru and tissue levels of a horone that is structurally identical to endogenous progesterone. It was suggested that it is functionally equivalent to synthetic progesteron for coon applications, such as secondary aenorrhea, while offering the advantage of a ore physiologic etabolic profile that could be iportant for sustained use in applications such as postenopausal horone replaceent therapy. It is an Open label, Randoized, Multicentric, Parallel group, 4 ar, Coparative Phase III study to evaluate the Efficacy and Safety of Progesterone SR oral tablets versus Progesterone oral tablets in woen with secondary aenorrhea associated with noral estrogen levels. A total of 388 subjects planned to randoized into one of the four ars.the total treatent period will be 90 days. A total 388 subjects planned to be randoized to either treatent group or control group only after satisfying all inclusion and exclusion criteria. Patients are requested to visit on next day after Screening date (Day 0), Day 30, Day 60, and Day 90. The efficacy will be calculated by change in Inducing withdrawal bleeding, and aintaining regular bleeding, in woen fro base line to end of the study. So current study is designed to assess the Efficacy and Safety of Progesterone SR oral tablets versus Progesterone oral tablets in woen with secondary aenorrhea associated with noral estrogen levels. page 5 / 5