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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00160420
• Collaborator: (none)
• Enrollment: 73
• Arm: 1
• Duration (Months): 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Asoprisnil	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Jul 1, 2004
• Actual Study Completion Date: Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil; 5mg Tablet, oral Daily for 12 months

Outcome Measures

Primary Outcome Measures

1. Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale. [Months 1,3,6,9,12 and final visit]

2. 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

1. Percentage of subjects with amenorrhea. [Throught treatment period.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Abbott

Investigators

• Study Chair: Medical Director, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00160420
• Other Study ID Numbers: M02-408
• First Posted: Sep 12, 2005
• Last Update Posted: May 29, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Pelvic pain; Dysmenorrhea; Dyspareunia; Infertility; asoprisnil
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of May 29, 2008