Comparison of IN-SYB-01 with Levonorgestrel in Women Seeking Emergency Contraception within 120 Hours of Unprotected Intercourse

Phase 3

• Registration Number: CTRI/2012/10/003077
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified