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A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

NCT00160459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2008-05-29

No results posted yet for this study

Summary

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

Conditions

  • Leiomyoma

Interventions

DRUG

Asoprisnil

5 mg Tablet, oral Daily for 12 weeks

DRUG

Asoprisnil

10 mg Tablet, oral Daily for 12 weeks

DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 weeks

DRUG

Placebo

Tablet, oral Daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2001-07-31
Completion
2001-07-31

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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 NCT00160459 on ClinicalTrials.gov