Safety and Efficacy of CDB-2914 for Emergency Contraception

Emergency Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411684
• Other study ID #: 2914-005
• Status: Completed
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: June 5, 2009

Study information

• Verified date: April 2021
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 1623
• Est. completion date: June 5, 2009
• Est. primary completion date: April 8, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Contraception

Intervention

Drug:
• CDB-2914

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fine P, Mathé H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	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	Up to 60 days after enrollment
Secondary	Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)	Number of prevented pregnancies divided by the number of expected pregnancies	within the menstrual cycle of the unprotected Intercourse
Secondary	Impact on Menstrual Bleeding Patterns	Menstrual cycle length post treatment	within the menstrual cycle of the unprotected Intercourse
Secondary	Frequencies of Subjects With Treatment Emergent Adverse Events	Most common related adverse events in ITT population.	12-14 days after expected menses