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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