Status:

COMPLETED

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

Lead Sponsor:

Abbott

Conditions:

Leiomyoma

Eligibility:

FEMALE

18-48 years

Phase:

PHASE2

Brief Summary

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.

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, afte...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2001

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT00156182

Start Date

April 1 2001

End Date

December 1 2001

Last Update

March 4 2009

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