Trials / Completed
CompletedNCT01107093
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- HRA Pharma · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CDB-2914 (ulipristal acetate) | single oral dose of 30 mg |
| DRUG | Placebo | single oral dose |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2010-04-20
- Last updated
- 2010-08-25
Locations
2 sites across 2 countries: Chile, Dominican Republic
Source: ClinicalTrials.gov record NCT01107093. Inclusion in this directory is not an endorsement.