None listed
Conditions
Interventions
Intervention1: Ulipristal Acetate Tablets 30 mg: Ulipristal Acetate Tablet 30 mg to be taken orally not later than 120 hours (5 days) after unprotected intercourse or contraceptive failure (Single Ora
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged >=18 & 2. History of regular menstrual cycles (mean length of 24-40 days with intra-individual variation of ±5 days). 3. Woman reports that all acts of unprotected coitus during the current cycle are within 72 hours (for reference product) or 120 hours (for test product) prior to enrolment. 4. Request for emergency contraceptive within 72 hours (for reference product) or 120 hours (for test product) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure.
Exclusion criteria
Exclusion criteria: 1. Women 40 years of age. 2. History of hypersensitivity to the study drug or reference drug or related products. 3. Patients with history of lactose intolerance. 4. Use of hormonal methods of contraception during the current or previous two cycles or whose partner was sterilized. 5. Participation in a clinical trial with an investigation drug within 30 days preceding day 1 of this study. 6. Women reports that all acts of unprotected coitus during the current cycle are more than 120 hours prior to enrolment. 7. Women who are pregnant or breastfeeding. 8. History of severe hepatic impairment. 9. History of severe asthma insufficiently controlled by oral glucocorticoids. 10. History of acute porphyria. 11. Any other condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate in women who received emergency contraception within 72 hours after unprotected sexual intercourse. Pregnancy rate women who received emergency contraception within 120 hours after unprotected sexual intercourse (only for Test product). Detection of early pregnancy shall be assessed by UPT (urine pregnancy test) and results will be recorded as per investigatorâ??s observation. Timepoint: 120 Hours for Test Product 72 Hours for Reference Product | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy rate in women who received emergency contraception between used 48 and â?¤ 72 hours after unprotected sexual intercourse. Pregnancy rate in women who received emergency contraception between 72 and â?¤ 96 hours after unprotected sexual intercourse (For Test product only). Pregnancy rate in women who received emergency contraception between 96 and â?¤ 120 hours after unprotected sexual intercourse (For Test product only). Timepoint: 120 Hours for Test Product 72 Hours for Reference Product | — |
Countries
India
Contacts
Public ContactRahul Vij
Synokem Pharmaceuticals Ltd.
Outcome results
None listed