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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HRA Pharma
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• 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 IUD for emergency contraception

• Able to provide informed consent

• Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion Criteria:

• 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