Safety and Efficacy of CDB-2914 for Emergency Contraception

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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 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

Arm && Interventions

Group	Intervention	Description
CDB-2914	CDB-2914	A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	Up to 60 days after enrollment	A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after

Secondary Outcome Measures

Name	Time	Method
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)	within the menstrual cycle of the unprotected Intercourse	Number of prevented pregnancies divided by the number of expected pregnancies
Impact on Menstrual Bleeding Patterns	within the menstrual cycle of the unprotected Intercourse	Menstrual cycle length post treatment
Frequencies of Subjects With Treatment Emergent Adverse Events	12-14 days after expected menses	Most common related adverse events in ITT population.

Locations (17): Planned Parenthood of Maryland
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Baltimore, Maryland, United States
Planned Parenthood League of Massachusetts
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Boston, Massachusetts, United States
Planned Parenthood of Greater Cleveland
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Cleveland, Ohio, United States
Planned Parenthood of Houston and Southeast Texas
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Houston, Texas, United States
Planned Parenthood of Western Washington
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Seattle, Washington, United States
Planned Parenthood of South Palm Beach, Pembroke Pines
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Pembroke Pines, Florida, United States
Planned Parenthood of Greater Iowa
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Ames, Iowa, United States
Planned Parenthood of Columbia-Willamette
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Portland, Oregon, United States
Planned Parenthood of the Texas Capital Region
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Austin, Texas, United States
Planned Parenthood of the Rocky Mountains
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Denver, Colorado, United States
Planned Parenthood of Mar Monte
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San Jose, California, United States
Planned Parenthood of Mid-Michigan Alliance
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Ann Arbor, Michigan, United States
Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
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Miami, Florida, United States
Planned Parenthood of SE Philadelphia
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Philadelphia, Pennsylvania, United States
Planned Parenthood of Minnesota
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Minneapolis, Minnesota, United States
Planned Parenthood Association of Utah
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Salt Lake City, Utah, United States
Planned Parenthood of Indiana
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Bloomington, Indiana, United States