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Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

NCT00290251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-15

Study results available
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Summary

This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.

Conditions

  • Leiomyoma

Interventions

DRUG

ulipristal acetate 20 mg

ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic

DRUG

ulipristal acetate 10 mg

10 mg given daily for three menstrual cycles or 90 - 102 days

DRUG

placebo

placebo given once daily for 3 menstrual cycles or 90 - 102 days

Sponsors & Collaborators

  • HRA Pharma

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Lynnette K Nieman, MD · NICHD, NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-07-31
Completion
2010-08-31

Countries

  • United States

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 NCT00290251 on ClinicalTrials.gov