Safety and Efficacy of CDB-2914 for Emergency Contraception

Completed · Phase 3

Conditions studied: Emergency Contraception

In brief

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.

Key facts

Study ID

NCT00411684

Run by

HRA Pharma

People needed

1623

Starts

2006-11-01

Expected to finish

2009-06-05

Last updated by the study team

2021-09-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 current cycle) within 48 hours of presentation
• Currently pregnant as confirmed by positive HSUP test performed at screening
• Currently breast-feeding
• Current use of hormonal contraception
• Use of hormonal emergency contraception since last menstrual period
• Current use of IUD
• Tubal ligation
• Partner with a vasectomy
• Unsure about the date of the last menstrual period
• Severe asthma insufficiently controlled by oral glucocorticoid
• Currently enrolled in any other trial of an investigational medicine

Where it is running

• Planned Parenthood of Mar Monte — San Jose, California, United States
• Planned Parenthood of the Rocky Mountains — Denver, Colorado, United States
• Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost — Miami, Florida, United States
• Planned Parenthood of South Palm Beach, Pembroke Pines — Pembroke Pines, Florida, United States
• Planned Parenthood of Indiana — Bloomington, Indiana, United States
• Planned Parenthood of Greater Iowa — Ames, Iowa, United States
• Planned Parenthood of Maryland — Baltimore, Maryland, United States
• Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States
• Planned Parenthood of Mid-Michigan Alliance — Ann Arbor, Michigan, United States
• Planned Parenthood of Minnesota — Minneapolis, Minnesota, United States
• Planned Parenthood of Greater Cleveland — Cleveland, Ohio, United States
• Planned Parenthood of Columbia-Willamette — Portland, Oregon, United States
• Planned Parenthood of SE Philadelphia — Philadelphia, Pennsylvania, United States
• Planned Parenthood of the Texas Capital Region — Austin, Texas, United States
• Planned Parenthood of Houston and Southeast Texas — Houston, Texas, United States
• Planned Parenthood Association of Utah — Salt Lake City, Utah, United States
• Planned Parenthood of Western Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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