A Randomized, Open Label, Active-Controlled, Multicentre, Prospective, Comparative, Phase III Clinical Study to assess the Efficacy, Safety and Tolerability of Ulipristal Acetate Tablets 30 mg Versus Levonorgestrel Tablets 1.5 mg in the women requiring emergency contraception for unprotected sexual intercourse or contraceptive failure.

Synokem Pharmaceuticals Ltd0 个研究点目标入组 102 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Women aged >=18 & <= 40 years of age.
•2. History of regular menstrual cycles (mean length of 24-40 days with intra-individual variation of Â±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.

•1. Women < 18 & >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.

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