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A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

NCT00152256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2008-05-29

No results posted yet for this study

Summary

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Conditions

  • Fibroid Uterus
  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia
  • Uterine Fibroids

Interventions

DRUG

Asoprisnil

Asoprisnil 10 mg Tablet, oral Daily for 6 months

DRUG

Asoprisnil

Asoprisnil 25mg Tablet, oral Daily for 6 months

DRUG

Placebo

Placebo Tablet, oral Daily for 6 months

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
53 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-02-28
Completion
2005-02-28

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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 NCT00152256 on ClinicalTrials.gov