Safety and Efficacy of CDB-2914 for Emergency Contraception

HRA Pharma

Status and phase: Completed; Phase 3

Conditions: Emergency Contraception

Treatments: Drug: CDB-2914

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411684

2914-005

Details and patient eligibility

About

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.

Enrollment: 1,623 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,623 participants in 1 patient group

CDB-2914

Experimental group

Description:

A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse

Treatment:

Drug: CDB-2914