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

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

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

Study placed in the following topic categories:

Emergencies

Additional relevant MeSH terms:

Disease Attributes

Pathologic Processes

ClinicalTrials.gov processed this record on October 15, 2008

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