Safety and Efficacy of CDB-2914 for Emergency Contraception (NCT00411684) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of CDB-2914 for Emergency Contraception
United States1,623 participantsStarted 2006-11
Plain-language summary
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or more
* Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
* Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
* No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
* For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
* Willing to not use hormonal methods of contraception until study completion
* At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
* Able to provide informed consent in English
* Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
* Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained
Exclusion Criteria:
* One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
* All acts of unprotected intercourse (in the c…