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

Contraception Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551616
• Other study ID #: 2914-004
• Status: Completed
• Phase: Phase 3
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2022
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2221
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• CDB-2914
Single dose
• Levonorgestrel
Single dose

Locations

Country	Name	City	State
Ireland	Well Woman Centre	Dublin
United Kingdom	NHS Grampian Sexual and Reproductive Health	Aberdeen
United Kingdom	Brook Family Planning Clinic	Belfast
United Kingdom	NHS Lothian Family Planning Service	Edinburgh
United Kingdom	NHS Greater Glasgow & Clyde Family Planning Service	Glasgow
United Kingdom	Liverpool PCT Family Planning Services	Liverpool
United Kingdom	London Sexual and Reproductive Health	London
United Kingdom	Manchester Primary Care Trust	Manchester
United Kingdom	Nottingham Contraception & Sexual Health Service	Nottingham
United Kingdom	Oxfordshire PCT Community Health	Oxford
United States	Planned Parenthood of Northeast Ohio Akron Health Center	Akron	Ohio
United States	Planned Parenthood of Texas Capitol Region	Austin	Texas
United States	Planned Parenthood of Northeast Ohio Bedford Health Center	Bedford	Ohio
United States	Planned Parenthood of the Rocky Mountains	Boulder	Colorado
United States	Planned Parenthood of Northeast Ohio East Cleveland Health Center	Cleveland	Ohio
United States	Planned Parenthood of Northeast Ohio Old Brooklyn Health Center	Cleveland	Ohio
United States	Planned Parenthood of the Rocky Mountains	Denver	Colorado
United States	Fannin Health Center	Houston	Texas
United States	Planned Parenthood of Houston and Southeast Texas Research Department	Houston	Texas
United States	Planned Parenthood of Northeast Ohio Kent Health Center	Kent	Ohio
United States	Planned Parenthood of Greater Miami	Lake Worth	Florida
United States	Planned Parenthood of the Rocky Mountains	Littleton	Colorado
United States	Planned Parenthood Hollywood	Los Angeles	California
United States	Planned Parenthood of Greater Miami	Miami	Florida
United States	Planned Parenthood of Greater Miami	North Miami	Florida
United States	Planned Parenthood Association of Utah	Ogden	Utah
United States	Planned Parenthood Association of Utah	Orem	Utah
United States	Planned Parenthood of Northeast Ohio Rocky River Health Center	Rocky River	Ohio
United States	Planned Parenthood Association of Utah	Salt Lake City	Utah
United States	Planned Parenthood Santa Monica	Santa Monica	California
United States	Planned Parenthood of Greater Miami	Stuart	Florida
United States	Planned Parenthood of Greater Miami	West Palm Beach	Florida
United States	Planned Parenthood Association of Utah	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Countries where clinical trial is conducted

United States,  Ireland,  United Kingdom, 

References & Publications (1)

Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-anal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pregnancy	The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.	Within 72 hours of unprotected Intercourse
Secondary	Actual Pregnancy Rate Compared to Expected Pregnancy Rate	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.	Within 120 hours of unprotected Intercourse
Secondary	Menstrual Bleeding Patterns	Onset of next menses after emergency contraception compared to usual date.	within the menstrual cycle of the unprotected Intercourse