Safety and Efficacy of CDB-2914 for Emergency Contraception

August 27, 2021 updated by: HRA Pharma

A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1623

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

  • United States
    • California
      • San Jose, California, United States, 95126
        • Planned Parenthood of Mar Monte
    • Colorado
      • Denver, Colorado, United States, 80203
        • Planned Parenthood of the Rocky Mountains
    • Florida
      • Miami, Florida, United States
        • Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
      • Pembroke Pines, Florida, United States
        • Planned Parenthood of South Palm Beach, Pembroke Pines
    • Indiana
      • Bloomington, Indiana, United States
        • Planned Parenthood of Indiana
    • Iowa
      • Ames, Iowa, United States
        • Planned Parenthood of Greater Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Planned Parenthood of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Planned Parenthood League of Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States
        • Planned Parenthood of Mid-Michigan Alliance
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Planned Parenthood of Minnesota
    • Ohio
      • Cleveland, Ohio, United States
        • Planned Parenthood of Greater Cleveland
    • Oregon
      • Portland, Oregon, United States, 97206
        • Planned Parenthood of Columbia-Willamette
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Planned Parenthood of SE Philadelphia
    • Texas
      • Austin, Texas, United States
        • Planned Parenthood of the Texas Capital Region
      • Houston, Texas, United States, 77004
        • Planned Parenthood of Houston and Southeast Texas
    • Utah
      • Salt Lake City, Utah, United States
        • Planned Parenthood Association of Utah
    • Washington
      • Seattle, Washington, United States, 98122
        • Planned Parenthood of Western Washington

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 18 years or more
  • Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
  • Request emergency contraception between 48 hours and 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 delivery, miscarriage or abortion
  • 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

Exclusion Criteria:

  • One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
  • All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
  • Currently pregnant as confirmed by positive HSUP test performed at screening
  • 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 an investigational medicine

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDB-2914
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
Drug: CDB-2914

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: Up to 60 days after enrollment

A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points:

  • 5-7 days after expected date of menses
  • 1 week later
  • every two week after
Up to 60 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Time Frame: within the menstrual cycle of the unprotected Intercourse
Number of prevented pregnancies divided by the number of expected pregnancies
within the menstrual cycle of the unprotected Intercourse
Impact on Menstrual Bleeding Patterns
Time Frame: within the menstrual cycle of the unprotected Intercourse
Menstrual cycle length post treatment
within the menstrual cycle of the unprotected Intercourse
Frequencies of Subjects With Treatment Emergent Adverse Events
Time Frame: 12-14 days after expected menses
Most common related adverse events in ITT population.
12-14 days after expected menses

Collaborators and Investigators

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

Sponsor

HRA Pharma

Investigators

  • Principal Investigator: Paul Fine, MD, Planned Parenthood of Houston and Southeast Texas

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

November 1, 2006

Primary Completion (Actual)

April 8, 2008

Study Completion (Actual)

June 5, 2009

Study Registration Dates

First Submitted

December 13, 2006

First Submitted That Met QC Criteria

December 13, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-005

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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