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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2001-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leiomyoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

10mg Tablet, oral Daily for 6 months

Interventions

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Asoprisnil

10mg Tablet, oral Daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No