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

April 11, 2022 updated by: HRA Pharma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDB-2914
Drug: CDB-2914
Single dose
Active Comparator: Levonorgestrel
Drug: Levonorgestrel
Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Pregnancy
Time Frame: Within 72 hours of unprotected Intercourse
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Within 72 hours of unprotected Intercourse

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Time Frame: 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.
Within 120 hours of unprotected Intercourse
Menstrual Bleeding Patterns
Time Frame: within the menstrual cycle of the unprotected Intercourse
Onset of next menses after emergency contraception compared to usual date.
within the menstrual cycle of the unprotected Intercourse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRA Pharma

Investigators

  • Principal Investigator: Anna F Glasier, MD, NHS Lothian Family Planning Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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