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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 19:04:09 GMT)

CTRI Number CTRI/2012/10/003077 [Registered on: 29/10/2012] - Trial Registered Retrospectively Last Modified On 01/03/2013 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Preventive Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Comparison of IN-SYB-01 with Levonorgestrel in Women Seeking Emergency Contraception within 120 Hours of Unprotected Intercourse Scientific Title of An Open Label, Phase III Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Study evaluation of Efficacy and Safety of IN-SYB-O1 in Comparison with Levonorgestrel in Women Seeking Emergency Contraception within 120 Hours of Unprotected Intercourse. Secondary IDs if Any Secondary ID Identifier CT/ IN-SYB-O1/EC/III/11, Version No.: 00; Date: Protocol Number 30/08/2011 Details of Principal Details of Principal Investigator Investigator or overall Name Dr Rane Trial Coordinator (multi-center study) Designation Senior Vice President Affiliation Intas Pharmaceuticals Ltd Address Medical Services Department Intas Pharmaceuticals Ltd 7th floor Premier House 1 Gandhinagar Sarkhej Highway Bodakdev Ahmedabad Ahmadabad GUJARAT 380054 India Phone 66117401 Fax 26840224 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sonal Mehta Query) Designation Medical Advisor Affiliation Intas Pharmaceuticals Ltd Address Medical Services Department Intas Pharmaceuticals Ltd 7th floor Premier House 1 Gandhinagar Sarkhej Highway Bodakdev Ahmedabad India Ahmadabad GUJARAT 380054 India Phone 66117404 Fax 26840224 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Dimple Shah Designation Senior Manager Affiliation Intas Pharmaceuticals Ltd Address Medical Services Department Intas Pharmaceuticals Ltd 7th floor Premier House 1 Gandhinagar Sarkhej Highway Bodakdev

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Ahmedabad India Ahmadabad GUJARAT 380054 India Phone 66117405 Fax 26840224 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Intas Pharmaceuticals Limited Ahmedabad Primary Sponsor Primary Sponsor Details Name Intas Pharmaceuticals Limited Address Intas Pharmaceuticals Limited 2nd Floor Chinubhai Center Ashram Road Ahmedabad 380009 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Milind Gaitonde Abhiman Maternity and Teen Hath Naka Nr L B 9821028774 Surgical Hospital S Marg Thane W 400 602 milind_gaitonde@yaho Thane o.com Dr Lila Vyas Dr Lila Vyas clinic 10 525 Opp Saini Criket 01412392199 Stadium Madhyam Marg Mansarovar [email protected] Jaipur 302020 m Jaipur RAJASTHAN Dr Seema Sehgal Gynec surgery and C 6 Rajouri Garden 9811078189 infertility clinic Attached to M K W Hospital J Block Rajouri sehgalseema27@gmail Garden New Delhi .com 110027 New Delhi DELHI Dr Vipul Patel Hradayi womens 24 Silver star Complex 9898254254 hospital Chandlodia Gota Road Ahmedabad 380015 [email protected] Ahmadabad GUJARAT Dr Vandna Amin Ladycare womens Swaminarayan Avenue 9824011818 hospital and childcare B AEC Cross road 132 Feet Ring Road [email protected] Naranpura Ahmedabad 13 Ahmadabad GUJARAT Dr V R Ambiye Mahalaxmi Clinic 270 1 Nandham Opp 02224044912 Gate No 7 Sion Hospital Sion W [email protected]

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Mumbai 22 MAHARASHTRA Dr Indrajit Mulik Mulik hospital and Opp Dhantoli Garden 09823051564 research centre Nagpur 440012 Maharashtra [email protected] Nagpur MAHARASHTRA Dr Atul Praful Munshi Munshi Hospital 50 Pritamnagar Ellis 09824021000 bridge Ahmedabad 380006 [email protected] Ahmadabad GUJARAT Dr Rajesh Punjabi Shashwat IVF centre 2nd Floor Neelkanth 09909560081 Palace Opp Seema Hall Ananadnagar 100 ft drshitalpunjabi@yahoo. road Satellite com Ahmedabad 380 015 Ahmadabad GUJARAT Dr Sudhir Naik Shree Guru Maternity B 101 102 103 Aakar 9820149368 and Children Nursing Apartments Gen A K Home Vaidya Marg [email protected] Road Opp Wagheshwari Temple EasT Mumbai 400063 Mumbai MAHARASHTRA Dr Anita Goyal Shree Krishna Hospital Plot No 1 31 09314393617 Vidhyadhar Nagar Jaipur 302023 [email protected] Jaipur m RAJASTHAN Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? EtiikkaIndependentEthi Approved 20/04/2012 Yes csCommittee/Mumbai/D rAmbiye EtiikkaIndependentEthi Approved 20/04/2012 Yes csCommittee/Mumbai/D rGaitonde EtiikkaIndependentEthi Approved 20/04/2012 Yes csCommittee/Mumbai/D rNaik NagpurIndependentEthi Approved 13/04/2012 Yes csCommittee/Nagpur/D rMulik SiddhantIndependentEt Approved 13/04/2012 Yes hicsCommittee/ahmeda bad/DrMunshi SiddhantIndependentEt Approved 13/04/2012 Yes hicsCommittee/Ahmeda bad/DrPunjabi SiddhantIndependentEt Approved 13/04/2012 Yes hicsCommittee/Ahmeda bad/DrVandana

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SiddhantIndependentEt Approved 13/04/2012 Yes hicsCommittee/Ahmeda bad/DrVipul SPECTERB/NewDelhi/ Approved 30/05/2012 Yes DrSeema SwasthyakalyanEthicsC Approved 21/06/2012 Yes ommittee/Jaipur/DrAnit a Regulatory Clearance Status Date Status from DCGI Approved/Obtained 31/07/2012 Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Emergency Contraception Intervention / Type Name Details Comparator Agent Intervention IN-SYB-O1 (Ulipristal acetate To receive a single, supervised 30 mg tablet) dose of one tablet IN-SYB-O1 orally Comparator Agent Levonorgestrel 1.5 mg tablet To receive a single, supervised (Brand: I-Pill marketed by dose of one tablet Piramal Healthcare) levonorgestrel 1.5 mg orally. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 45.00 Year(s) Gender Female Details 1. Women aged 18 to 45 years seeking emergency contraception within 120 hours of unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure.
2. Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days.
3. No history of amenorrhea.
4. No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception.
5. For women who present more than 72 hours after intercourse, decline the insertion of an IUD for emergency contraception
6. Able to give voluntary, written informed consent, and agree to comply with all study requirements (such as regular recording of diary, the subject needs to be available for follow-up over the next 6 weeks,).
7. Willing to abstain from further acts of unprotected intercourse until study completion.

Exclusion Criteria Exclusion Criteria Details 1. One or more acts of unprotected intercourse more than 120 hours before requesting emergency contraception in the current menstrual cycle. 2. Currently pregnant or breastfeeding 3. Current or recent use of hormonal methods of contraception 4. Tubal ligation or current use of IUD 5. History of any chronic illnesses such as asthma, hepatic, renal or cardiac disease. 6. Clinically significant abnormalities on physical examination. 7. Ongoing use of medications including carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, topiramate, bosentan, proton pump inhibitors, H2 receptor antagonists and antacids

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Method of Generating Computer generated randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Pregnancy rate in women who received 6 Weeks emergency contraception within 120 hours of unprotected sexual intercourse. The pregnancy rate, calculated as the number of pregnancies after emergency contraception divided by the total number of women exposed to emergency contraception for whom pregnancy status is known Secondary Outcome Outcome Timepoints Prevented fraction: 1– (number of pregnancies 6 Weeks observed after treatment divided by estimated expected number of pregnancies that would occur without treatment) Target Sample Size Total Sample Size=240 Sample Size from India=240 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3 Date of First 02/10/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Brief Summary The aim of this study is to evaluate the efficacy and safety of IN-SYB-O1 in comparison with levonorgestrel in women seeking emergency contraception within 120 hours of unprotected intercourse. 50% female subjects (120 subjects) will be those who are seeking emergency contraception within 72 hours of unprotected intercourse & 50% subjects (120 subjects) will be those who are seeking emergency contraception between 72 & 120 hours of unprotected intercourse. Each participant seeking emergency contraception will receive either a single, supervised dose of one tablet IN-SYB-O1 or one tablet levonorgestrel 1.5 mg orally. Primary efficacy parameter will be pregnancy rate in women who received emergency contraception within 120 hours of unprotected sexual intercourse

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