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

NCT00160381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2008-05-29

No results posted yet for this study

Summary

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Conditions

  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia

Interventions

DRUG

Asoprisnil

10mg Tablet, oral Daily for 12 months

DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 months

DRUG

Placebo

Tablet, oral Daily for 12 months

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2005-01-31
Completion
2005-01-31

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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 NCT00160381 on ClinicalTrials.gov