Efficacy Trial of CDB 2914 for Emergency Contraception

December 13, 2007 updated by: University of Pittsburgh

A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception

Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.

Study Overview

Status

Completed

Conditions

Emergency Contraception

Intervention / Treatment

Detailed Description

Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Duration: A one-time treatment with either CDB-2914 or levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

Treatment: A one-time treatment with one of the following:

Two doses of 0.75 mg of levonorgestrel to be taken 12 hours apart
One dose of 50 mg CDB-2914 and a second placebo dose to be taken 12 hours later

Study Sites: Multicenter study in the United States

Subjects: Women of reproductive age (at least 18 years) at risk of pregnancy within 72 hours of unprotected coitus

Sample Size: Approximately 811 women will be enrolled in each treatment group to obtain 1540 evaluable subjects

Outcome Evaluations

Primary: To evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.

Secondary: To compare the tolerability (as measured by vomiting and nausea) of CDB-2914 used by subjects as an emergency postcoital contraceptive with that of a group of subjects receiving levonorgestrel.

Safety/Other: To assess the frequency and intensity of adverse events and the effects on the menstrual cycle of subjects administered CDB-2914 in comparison to subjects given levonorgestrel.

Study Type

Interventional

Enrollment (Actual)

1672

Phase

Phase 2
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
  - Los Angeles, California, United States
    - California Family Health Council
- Colorado
  - Denver, Colorado, United States
    - University of Colorado
- New York
  - New York, New York, United States
    - New York University
- Ohio
  - Cincinnati, Ohio, United States
    - University of Cincinnati
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15215
    - University of Pittsburgh
- Virginia
  - Norfolk, Virginia, United States
    - Eastern Virginia Medical School

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Menstruating women at least 18 years old;
Give voluntary, written informed consent, and agree to observe all study requirements;
Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
Willing to abstain from further acts of unprotected intercourse during that cycle;
History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
At least one normal menstrual cycle (2 menses) post delivery or abortion;
If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
Available for follow-up for at least the next four weeks.

Exclusion Criteria:

Currently pregnant (positive high-sensitivity urine pregnancy test);
pregnant or breast-feeding within the past two months;
use of hormonal methods of contraception during the current or previous two cycles;
current user of IUD;
tubal ligation;
partners with history of vasectomy;
unsure about the date of the last menstrual period (+3 days);
irregular menstrual cycles as defined in the inclusion criteria;
nausea and vomiting within the previous two weeks;
impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.

Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this 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: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pregnancy (efficacy) Time Frame: until follow-up about one week after next menses	until follow-up about one week after next menses

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability (side effects) Time Frame: until follow-up about one week after next menses	until follow-up about one week after next menses
Menstrual cycle effects Time Frame: until follow-up about one week after next menses	until follow-up about one week after next menses

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator: Diana Blithe, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, Rosenberg M, Higgins J. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1089-97. doi: 10.1097/01.AOG.0000239440.02284.45.

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

September 1, 1999

Study Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria