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

Completed · Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00551616

Run by

HRA Pharma

People needed

2221

Starts

2007-04-01

Expected to finish

2009-04-01

Last updated by the study team

2022-05-03

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
• present within 120 hours of unprotected intercourse
• regular menstrual cycles
• No current use of hormonal contraception
• Willing to not use hormonal methods of contraception until study completion
• At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
• For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
• Able to provide informed consent
• Willing to abstain from further acts of unprotected intercourse until study completion

You may not qualify if…

• One or more acts of unprotected intercourse more than 120 hours
• current or recent use of hormonal methods of contraception
• currently pregnant or breastfeeding
• tubal ligation or current use of IUD
• 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
• Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study

Where it is running

• Planned Parenthood Hollywood — Los Angeles, California, United States
• Planned Parenthood Santa Monica — Santa Monica, California, United States
• 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
• 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
• 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
• Planned Parenthood of Texas Capitol Region — Austin, Texas, United States
• Fannin Health Center — Houston, Texas, United States
• Planned Parenthood of Houston and Southeast Texas Research Department — Houston, Texas, United States
• 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
• Well Woman Centre — Dublin, Ireland
• NHS Grampian Sexual and Reproductive Health — Aberdeen, United Kingdom

Full record on ClinicalTrials.gov

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