None listed
Conditions
Interventions
Intervention1: IN-SYB-O1 (Ulipristal acetate 30 mg tablet): To receive a single, supervised dose of one tablet IN-SYB-O1 orally
Control Intervention1: Levonorgestrel 1.5 mg tablet (Brand: I-Pill marke
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate in women who received 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 knownTimepoint: 6 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevented fraction: 1â?? (number of pregnancies observed after treatment divided by estimated expected number of pregnancies that would occur without treatment)Timepoint: 6 Weeks | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Intas Pharmaceuticals Ltd
Outcome results
None listed