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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: Asoprisnil

• Registration Number: NCT00160420
• Lead Sponsor: Abbott

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 endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Asoprisnil	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.	Months 1,3,6,9,12 and final visit
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.	Months 3,6,9,12 and final visit

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with amenorrhea.	Throught treatment period.