Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Phase 3

Completed

• Conditions: Leiomyoma; Menorrhagia; Metrorrhagia
• Interventions: Drug: Asoprisnil

• Registration Number: NCT00156195
• Lead Sponsor: Abbott

Brief Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

Detailed Description

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 523

Inclusion Criteria

• Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
• Otherwise in good health
• Premenopausal based on Estrogen and FSH levels
• Agrees to use of double barrier method of contraception
• Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria

• Any abnormal lab or procedure result(s) the study-doctor considers important
• Significant gynecological disorder such as confirmed endometrial polyp
• Hemoglobin < 8.0 g/dL
• History of a blood-clotting disorder
• Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Asoprisnil	-
2	Asoprisnil	-

Primary Outcome Measures

Name	Time	Method
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.	Month 12

Secondary Outcome Measures

Name	Time	Method
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.	Month 6
Change from baseline in menstrual pictogram bleeding score.	Final Month
Change from baseline in the number of days with bleeding.	Final Month
Change from baseline in hemoglobin concentration.	Final Visit
Percent change from baseline in the volume of the largest fibroid.	Final Visit
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.	Final Visit
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.	Final Visit
Cumulative percent of subjects who achieve amenorrhea.	Each Month