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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pública de Chile
Dominican Republic: Consejo Nacional de Bioetica en Salud

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2014