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

NCT01107093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-08-25

No results posted yet for this study

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

  • Contraception

Interventions

DRUG

CDB-2914 (ulipristal acetate)

single oral dose of 30 mg

DRUG

Placebo

single oral dose

Sponsors & Collaborators

  • HRA Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Chile
  • Dominican Republic

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107093 on ClinicalTrials.gov