Status:

COMPLETED

A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

Lead Sponsor:

Abbott

Conditions:

Endometriosis

Eligibility:

FEMALE

18-40 years

Phase:

PHASE2

Brief Summary

The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

Detailed Description

Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometrios...

Eligibility Criteria

Inclusion

  • Completed 3 months of dosing and Month 3 procedures in study M01-398
  • Otherwise in good health
  • Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

Exclusion

  • Any abnormal lab or procedure result the study-doctor considers important
  • Anticipated need for excluded hormonal therapy or unapproved narcotics

Key Trial Info

Start Date :

December 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2004

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT00160420

Start Date

December 1 2002

End Date

July 1 2004

Last Update

May 29 2008

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