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

HRA Pharma

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: CDB-2914

Drug: Levonorgestrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00551616

2914-004

Details and patient eligibility

About

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.

Enrollment

2,221 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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 Intra Uterine Device 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