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

Phase 3

Completed

Conditions: Contraception

Interventions: Drug: CDB-2914
Drug: Levonorgestrel

Registration Number: NCT00551616

Lead Sponsor: HRA Pharma

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 2221

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDB-2914	CDB-2914	-
Levonorgestrel	Levonorgestrel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pregnancy	Within 72 hours of unprotected Intercourse	The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.

Secondary Outcome Measures

Name	Time	Method
Menstrual Bleeding Patterns	within the menstrual cycle of the unprotected Intercourse	Onset of next menses after emergency contraception compared to usual date.
Actual Pregnancy Rate Compared to Expected Pregnancy Rate	Within 120 hours of unprotected Intercourse	Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone \& Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.

Trial Locations

Locations (24): Planned Parenthood of the Rocky Mountains
🇺🇸
Littleton, Colorado, United States
Planned Parenthood of Texas Capitol Region
🇺🇸
Austin, Texas, United States
Planned Parenthood of Northeast Ohio Rocky River Health Center
🇺🇸
Rocky River, Ohio, United States
Planned Parenthood Association of Utah
🇺🇸
West Valley City, Utah, United States
NHS Grampian Sexual and Reproductive Health
🇬🇧
Aberdeen, United Kingdom
Brook Family Planning Clinic
🇬🇧
Belfast, United Kingdom
NHS Greater Glasgow & Clyde Family Planning Service
🇬🇧
Glasgow, United Kingdom
Nottingham Contraception & Sexual Health Service
🇬🇧
Nottingham, United Kingdom
London Sexual and Reproductive Health
🇬🇧
London, United Kingdom
Manchester Primary Care Trust
🇬🇧
Manchester, United Kingdom
Oxfordshire PCT Community Health
🇬🇧
Oxford, United Kingdom
Planned Parenthood Santa Monica
🇺🇸
Santa Monica, California, United States
Planned Parenthood Hollywood
🇺🇸
Los Angeles, California, 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 East Cleveland Health Center
🇺🇸
Cleveland, Ohio, United States
Fannin Health Center
🇺🇸
Houston, Texas, United States
Planned Parenthood of Houston and Southeast Texas Research Department
🇺🇸
Houston, Texas, United States
Well Woman Centre
🇮🇪
Dublin, Ireland
Liverpool PCT Family Planning Services
🇬🇧
Liverpool, United Kingdom
Planned Parenthood of Northeast Ohio Bedford Health Center
🇺🇸
Bedford, 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
NHS Lothian Family Planning Service
🇬🇧
Edinburgh, United Kingdom