A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerability of CDB-2914 with Levonorgestrel as Emergency Contraception Within 120 Hours Unprotected Intercourse ” (Phase III). - CDB-2914 vs LNG for EC

Phase 1

• Conditions: Emergency contraception

• Registration Number: EUCTR2006-003387-55-GB
• Lead Sponsor: aboratoire HRA Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-21
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 2044

Inclusion Criteria

- Aged 16 years or more;
- Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than 5 days;
- Request emergency contraception within 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 miscarriage, delivery or abortion;
- For women who present more than 72 hours after intercourse, decline the insertion of an IUD for emergency contraception and/or have contraindications to IUD insertion;
- 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- One or more acts of unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle;
- Currently pregnant as confirmed by positive HSUP test performed at screening (Treatment Visit);
- 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 investigational medicine
- hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified