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A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

NCT00150644 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2008-05-29

No results posted yet for this study

Summary

The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

Conditions

  • Uterine Fibroids
  • Leiomyoma

Interventions

DRUG

Asoprisnil

Asoprisnil 10mg Tablet, oral Daily for 12 weeks

DRUG

Asoprisnil

Asoprisnil 25 mg Tablet, oral Daily for 12 weeks

DRUG

Placebo

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
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2005-05-31
Completion
2005-05-31

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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 NCT00150644 on ClinicalTrials.gov