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

May 27, 2008 updated by: Abbott

A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between 18 and 49 years of age
  • Diagnosis of either 1 or more uterine fibroids
  • History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

  • Any abnormal lab result the study-doctor considers significant
  • History of severe reaction to or current use of hormone therapy
  • History of osteoporosis or other bone disease
  • History of uterine artery embolization, cryomyolysis, or electrical myolysis
  • Subject currently breast feeding
  • Hemoglobin < 8 g/dL at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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
Placebo Comparator: 4
Drug: Placebo
Tablet, oral Daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in uterine volume and volume of the largest fibroid.
Time Frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Time Frame: Day 1 to 1st post treatment menses
Day 1 to 1st post treatment menses

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in uterine size in gestational weeks.
Time Frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
Time Frame: Week 12 and final visit
Week 12 and final visit
Percentage of days with bleeding.
Time Frame: Day 1 through end of 1st post-treatment menses
Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.
Time Frame: Baseline to each visit
Baseline to each visit
Uterine fibroid symptom improvement.
Time Frame: Baseline to each visit
Baseline to each visit
Response to Global Efficacy Question regarding improvement in fibroid symptoms.
Time Frame: Week 12 and Final Visit
Week 12 and Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

July 1, 2001

Study Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M99-144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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