Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception - Full Text View

Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

This study is currently recruiting participants.
Verified by HRA Pharma, April 2008

Sponsored by:	HRA Pharma
Information provided by:	HRA Pharma
ClinicalTrials.gov Identifier:	NCT00551616

Purpose

The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.

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

MedlinePlus related topics:

Birth Control

ChemIDplus related topics:

Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by HRA Pharma:

Primary Outcome Measures:

Pregnancy rate

Secondary Outcome Measures:

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

Estimated Enrollment:	2044
Study Start Date:	April 2007

Arms	Assigned Interventions
1: Experimental	Drug: CDB-2914 Single dose
2: Active Comparator	Drug: Levonorgestrel Single dose

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women 16 or older
present within 120 hours of unprotected intercourse
regular menstrual cycles

Exclusion Criteria:

current or recent use of hormonal methods of contraception
currently pregnant or breastfeeding
tubal ligation or current use of IUD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551616

Contacts


Contact: Henri Mathé	+33 1 40 33 11 30	medical2914@hra-pharma.com

Locations


United Kingdom
	NHS Lothian Family Planning Service	Recruiting
	Edinburgh, United Kingdom
	NHS Grampian Sexual and Reproductive Health	Recruiting
	Aberdeen, United Kingdom
	NHS Greater Glasgow & Clyde Family Planning Service	Recruiting
	Glasgow, United Kingdom
	London Sexual and Reproductive Health	Recruiting
	London, United Kingdom
	Manchester Primary Care Trust	Recruiting
	Manchester, United Kingdom
	Liverpool PCT Family Planning Services	Recruiting
	Liverpool, United Kingdom
	Tayside Health Board Dundee & Perth Family Planning Services	Recruiting
	Dundee, United Kingdom

Sponsors and Collaborators

HRA Pharma

Investigators


Principal Investigator:	Anna F Glasier, MD	NHS Lothian Family Planning Service

More Information

Study ID Numbers:	2914-004
First Received:	October 30, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00551616
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Levonorgestrel

Emergencies

Additional relevant MeSH terms:

Contraceptive Agents

Therapeutic Uses

Contraceptives, Oral

Physiological Effects of Drugs

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Reproductive Control Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008