A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

March 3, 2009 updated by: Abbott

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Study Type

Interventional

Enrollment (Actual)

38

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

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Completed dosing and Day 84 procedures at sites in study M99-144
  • No interruption of dosing
  • Otherwise continued good health

Exclusion Criteria:

  • Any abnormal lab result the study-doctor considers significant
  • History of severe reaction to or current use of hormone therapy
  • History of alcohol or drug abuse

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Asoprisnil
10mg Tablet, oral Daily for 6 months

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 from pre-treatment in study M99-144
Time Frame: Treatment months 3 and 6 and Post-treatment months 3 and 6
Treatment months 3 and 6 and Post-treatment months 3 and 6
Percentage of subjects that achieved amenorrhea.
Time Frame: Treatment months 1-6
Treatment months 1-6

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in hematologic parameters.
Time Frame: Treatment months 2,4,and 6
Treatment months 2,4,and 6
Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale
Time Frame: Treatment Months 1-6
Treatment Months 1-6
Change from baseline in uterine size in gestational weeks.
Time Frame: Months 3 and 6
Months 3 and 6
Duration of amenorrhea.
Time Frame: Start of previous study to first post-treatment menses.
Start of previous study to first post-treatment menses.
Response to global efficacy question regarding improvement of fibroid symptoms.
Time Frame: Month 6
Month 6
Mean change from baseline for endocrine determinations.
Time Frame: Months 2,4 and 6
Months 2,4 and 6

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

April 1, 2001

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 3, 2009

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-275

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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