Safety and Efficacy of CDB-2914 for Emergency Contraception

NCT00411684 | Completed Phase 3 Results

• 1 other identifier: 2914-005
• Study Type: interventional
• Target: 1,623
• Locations: 1 country
• Sites: 17

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.

Conditions

Emergency Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)

  within the menstrual cycle of the unprotected Intercourse

• Impact on Menstrual Bleeding Patterns

  within the menstrual cycle of the unprotected Intercourse

• Frequencies of Subjects With Treatment Emergent Adverse Events

  12-14 days after expected menses

Study Arms (1)

CDB-2914

EXPERIMENTAL

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

Drug: CDB-2914

Interventions

CDB-2914 DRUG

CDB-2914

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• HRA Pharma: lead

Study Sites (17)

Planned Parenthood of Mar Monte

San Jose, California, 95126, United States

Location

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80203, United States

Location

Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost

Miami, Florida, United States

Location

Planned Parenthood of South Palm Beach, Pembroke Pines

Pembroke Pines, Florida, United States

Location

Planned Parenthood of Indiana

Bloomington, Indiana, United States

Location

Planned Parenthood of Greater Iowa

Ames, Iowa, United States

Location

Planned Parenthood of Maryland

Baltimore, Maryland, 21201, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Planned Parenthood of Mid-Michigan Alliance

Ann Arbor, Michigan, United States

Location

Planned Parenthood of Minnesota

Minneapolis, Minnesota, United States

Location

Planned Parenthood of Greater Cleveland

Cleveland, Ohio, United States

Location

Planned Parenthood of Columbia-Willamette

Portland, Oregon, 97206, United States

Location

Planned Parenthood of SE Philadelphia

Philadelphia, Pennsylvania, United States

Location

Planned Parenthood of the Texas Capital Region

Austin, Texas, United States

Location

Planned Parenthood of Houston and Southeast Texas

Houston, Texas, 77004, United States

Location

Planned Parenthood Association of Utah

Salt Lake City, Utah, United States

Location

Planned Parenthood of Western Washington

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Fine P, Mathe 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.

  PMID: 20093897 RESULT

MeSH Terms

Interventions

ulipristal

Results Point of Contact

• Title: Paul Carter - Chief Scientific Officer
• Organization: HRA Pharma

p.carter@hra-pharma.com

+33 1 40 33 11 30

Study Officials

• Paul Fine, MD

  Planned Parenthood of Houston and Southeast Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 14, 2006
• Study Start: November 1, 2006
• Primary Completion: April 8, 2008
• Study Completion: June 5, 2009
• Last Updated: September 21, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Locations

US (17)