Safety and Efficacy of CDB-2914 for Emergency Contraception - Full Text View

Sponsored by:	HRA Pharma
Information provided by:	HRA Pharma
ClinicalTrials.gov Identifier:	NCT00411684

Purpose

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.

Condition	Intervention	Phase
Emergency Contraception	Drug: CDB-2914	Phase III

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by HRA Pharma:

Primary Outcome Measures:

Pregnancy rate

Secondary Outcome Measures:

Prevented fraction (number of prevented pregnancies divided by the number of expected pregnancies)
Impact on menstrual bleeding patterns
Frequencies of subjects with treatment emergent adverse events

Estimated Enrollment:	1320
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411684

Locations

United States, California
Planned Parenthood of Mar Monte
San Jose, California, United States, 95126
United States, Colorado
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States, 80203
United States, Florida
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
United States, Indiana
Planned Parenthood of Indiana
Bloomington, Indiana, United States
United States, Iowa
Planned Parenthood of Greater Iowa
Ames, Iowa, United States
United States, Maryland
Planned Parenthood of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Planned Parenthood of Mid-Michigan Alliance
Ann Arbor, Michigan, United States
United States, Minnesota
Planned Parenthood of Minnesota
Minneapolis, Minnesota, United States
United States, Ohio
Planned Parenthood of Greater Cleveland
Cleveland, Ohio, United States
United States, Oregon
Planned Parenthood of Columbia-Willamette
Portland, Oregon, United States, 97206
United States, Pennsylvania
Planned Parenthood of SE Philadelphia
Philadelphia, Pennsylvania, United States
United States, Texas
Planned Parenthood of Houston and Southeast Texas
Houston, Texas, United States, 77004
Planned Parenthood of the Texas Capital Region
Austin, Texas, United States
United States, Utah
Planned Parenthood Association of Utah
Salt Lake, Utah, United States
United States, Washington
Planned Parenthood of Western Washington
Seattle, Washington, United States, 98122

Sponsors and Collaborators

HRA Pharma

Investigators

Principal Investigator:

Paul Fine, MD

Planned Parenthood of Houston and Southeast Texas

More Information

No publications provided

Study ID Numbers:	2914-005
Study First Received:	December 13, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00411684 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Emergencies

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Emergencies

ClinicalTrials.gov processed this record on May 06, 2009