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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01107093
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : August 25, 2010
Information provided by:
HRA Pharma

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Contraception Drug: CDB-2914 (ulipristal acetate) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Appearance or absence of a corpus luteum [ Time Frame: during the 6 days following treatment intake ]
  2. 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)

  3. 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.

  4. Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
  5. Incidence of intermenstrual bleeding and treatment-emergent adverse events
  6. Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
  7. Incidence of ovarian cysts after CDB-2914 treatment

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01107093

Santiago, Chile
Dominican Republic
Santo Domingo, Dominican Republic
Sponsors and Collaborators
HRA Pharma

Publications of Results:
Responsible Party: Erin Gainer, R&D Director, HRA Pharma Identifier: NCT01107093     History of Changes
Other Study ID Numbers: 2914-007
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Wounds and Injuries