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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Enrollment: | 2321 |
| Study Start Date: | April 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: CDB-2914
Single dose
|
| Active Comparator: 2 |
Drug: Levonorgestrel
Single dose
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Planned Parenthood Hollywood | |
| Los Angeles, California, United States | |
| Planned Parenthood Santa Monica | |
| Santa Monica, California, United States | |
| United States, Colorado | |
| Planned Parenthood of the Rocky Mountains | |
| Boulder, Colorado, United States | |
| Planned Parenthood of the Rocky Mountains | |
| Denver, Colorado, United States | |
| Planned Parenthood of the Rocky Mountains | |
| Littleton, Colorado, United States | |
| United States, Florida | |
| Planned Parenthood of Greater Miami | |
| Lake Worth, Florida, United States | |
| Planned Parenthood of Greater Miami | |
| Miami, Florida, United States | |
| Planned Parenthood of Greater Miami | |
| North Miami, Florida, United States | |
| Planned Parenthood of Greater Miami | |
| Stuart, Florida, United States | |
| Planned Parenthood of Greater Miami | |
| West Palm Beach, Florida, United States | |
| United States, Ohio | |
| Planned Parenthood of Northeast Ohio Akron Health Center | |
| Akron, Ohio, United States | |
| Planned Parenthood of Northeast Ohio Bedford Health Center | |
| Bedford, Ohio, United States | |
| Planned Parenthood of Northeast Ohio East Cleveland Health Center | |
| Cleveland, Ohio, United States | |
| Planned Parenthood of Northeast Ohio Old Brooklyn Health Center | |
| Cleveland, Ohio, United States | |
| Planned Parenthood of Northeast Ohio Kent Health Center | |
| Kent, Ohio, United States | |
| Planned Parenthood of Northeast Ohio Rocky River Health Center | |
| Rocky River, Ohio, United States | |
| United States, Texas | |
| Planned Parenthood of Texas Capitol Region | |
| Austin, Texas, United States | |
| Planned Parenthood of Houston and Southeast Texas Research Department | |
| Houston, Texas, United States | |
| Fannin Health Center | |
| Houston, Texas, United States | |
| United States, Utah | |
| Planned Parenthood Association of Utah | |
| Ogden, Utah, United States | |
| Planned Parenthood Association of Utah | |
| Orem, Utah, United States | |
| Planned Parenthood Association of Utah | |
| Salt Lake City, Utah, United States | |
| Planned Parenthood Association of Utah | |
| West Valley City, Utah, United States | |
| Ireland | |
| Well Woman Centre | |
| Dublin, Ireland | |
| United Kingdom | |
| NHS Grampian Sexual and Reproductive Health | |
| Aberdeen, United Kingdom | |
| Brook Family Planning Clinic | |
| Belfast, United Kingdom | |
| NHS Lothian Family Planning Service | |
| Edinburgh, United Kingdom | |
| NHS Greater Glasgow & Clyde Family Planning Service | |
| Glasgow, United Kingdom | |
| Liverpool PCT Family Planning Services | |
| Liverpool, United Kingdom | |
| London Sexual and Reproductive Health | |
| London, United Kingdom | |
| Manchester Primary Care Trust | |
| Manchester, United Kingdom | |
| Nottingham Contraception & Sexual Health Service | |
| Nottingham, United Kingdom | |
| Oxfordshire PCT Community Health | |
| Oxford, United Kingdom | |
| Principal Investigator: | Anna F Glasier, MD | NHS Lothian Family Planning Service |
More Information
| ClinicalTrials.gov Identifier: | NCT00551616 History of Changes |
| Other Study ID Numbers: | 2914-004 |
| Study First Received: | October 30, 2007 |
| Last Updated: | June 16, 2010 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Levonorgestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |