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

May 27, 2008 updated by: Abbott

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 3

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

18 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal women
  • History of regular menstrual cycles (21-42 days)
  • Diagnosis of uterine fibroid(s)
  • Abnormal vaginal bleeding associated with uterine fibroids
  • Otherwise in good health
  • Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

Exclusion Criteria:

  • Less than 3 months postpartum and post-lactation
  • Previous myomectomy within 1 year
  • Any abnormal lab or procedure result the study-doctor considers important
  • Severe reaction(s) to or are currently using any hormone therapy
  • History of osteoporosis or other bone disease

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
Asoprisnil 10 mg Tablet, oral Daily for 6 months
Other Names:
  • J867
Drug: Asoprisnil
Asoprisnil 25mg Tablet, oral Daily for 6 months
Other Names:
  • J867
Experimental: 2
Drug: Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for 6 months
Other Names:
  • J867
Drug: Asoprisnil
Asoprisnil 25mg Tablet, oral Daily for 6 months
Other Names:
  • J867
Placebo Comparator: 3
Drug: Placebo
Placebo Tablet, oral Daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative percent of subjects achieving amenorrhea.
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
Time Frame: Final Visit
Final Visit
Change from baseline in the Work Limitation Questionnaire Index.
Time Frame: Final Visit
Final Visit
Change from baseline in the hemoglobin concentration.
Time Frame: Final Visit
Final Visit
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Time Frame: Final Visit
Final Visit
Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
Time Frame: Final Visit
Final Visit
Change from baseline in the monthly bleeding score.
Time Frame: Final Visit
Final Visit
Change from baseline in volume of the largest fibroid.
Time Frame: Final Visit
Final Visit
Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.
Time Frame: During treatment period
During treatment period
Percentage of subjects who respond positively to the global efficacy question.
Time Frame: Final Visit
Final Visit

Collaborators and Investigators

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

Sponsor

Abbott

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

September 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 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

  • C02-037

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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