Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

August 24, 2010 updated by: HRA Pharma

A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:

  • echographic follicle rupture
  • inhibition of follicle rupture
  • luteal phase progesterone levels
  • anovulatory progesterone levels

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

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

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 to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women of good general health aged 18 - 35 years
  • Not at risk of pregnancy
  • Regular menstrual cycles of 24-35 days duration
  • Not pregnant
  • Intact uterus and ovaries
  • Haemoglobin ≥ 11 g/dl
  • Normal laboratory tests and normal TSH
  • Willing to abstain from any use of hormonal contraception until study completion
  • No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
  • Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
  • Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles

Exclusion Criteria:

  • Current participation in any other trial of an investigational medicine
  • Known hypersensitivity to the ingredients of the test active substances or excipients
  • Suspected hyperplasia or carcinoma of the endometrium
  • Current pregnancy as confirmed by positive serum beta-hCG at screening
  • Desire to get pregnant before the planned end of the study participation
  • Currently breastfeeding
  • Abnormal Pap smear
  • Cancer (past history of any carcinoma or sarcoma)
  • Known or suspected alcoholism or drug abuse
  • Abnormal thyroid status
  • Body mass index > 32
  • Current use of hormonal contraception
  • Use of hormonal emergency contraception since last menstrual period
  • Severe asthma insufficiently controlled by oral glucocorticoids
  • Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
single oral dose
Active Comparator: CDB-2914
Drug: CDB-2914 (ulipristal acetate)
single oral dose of 30 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibition of follicular rupture
Time Frame: within 6 days after treatment intake
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
within 6 days after treatment intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance or absence of a corpus luteum
Time Frame: during the 6 days following treatment intake
during the 6 days following treatment intake
Growth pattern of leading follicle
number of cycles exhibiting atresia (diameter decrease ≥25%), or continued growth (diameter increase ≥25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)
Presence or absence of a surge of serum luteinizing hormone (LH) levels
The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.
Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
Incidence of intermenstrual bleeding and treatment-emergent adverse events
Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
Incidence of ovarian cysts after CDB-2914 treatment

Collaborators and Investigators

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

Sponsor

HRA Pharma

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

May 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-007

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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Conditions

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Locations

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