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

This study has been completed.
Sponsor:
Information provided by:
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01107093
First received: April 12, 2010
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Contraception
Drug: CDB-2914 (ulipristal acetate)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • Inhibition of follicular rupture [ Time Frame: within 6 days after treatment intake ] [ Designated as safety issue: No ]
    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:
  • Appearance or absence of a corpus luteum [ Time Frame: during the 6 days following treatment intake ] [ Designated as safety issue: No ]
  • Growth pattern of leading follicle [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: Yes ]
  • Incidence of intermenstrual bleeding and treatment-emergent adverse events [ Designated as safety issue: Yes ]
  • Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline [ Designated as safety issue: Yes ]
  • Incidence of ovarian cysts after CDB-2914 treatment [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
single oral dose
Active Comparator: CDB-2914 Drug: CDB-2914 (ulipristal acetate)
single oral dose of 30 mg

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107093

Locations
Chile
ICMER
Santiago, Chile
Dominican Republic
Clinica de PROFAMILIA
Santo Domingo, Dominican Republic
Sponsors and Collaborators
HRA Pharma
  More Information

Publications:
Responsible Party: Erin Gainer, R&D Director, HRA Pharma
ClinicalTrials.gov Identifier: NCT01107093     History of Changes
Other Study ID Numbers: 2914-007
Study First Received: April 12, 2010
Last Updated: August 24, 2010
Health Authority: Chile: Instituto de Salud Publica de Chile
Dominican Republic: Consejo Nacional de Bioetica en Salud

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014