A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

Phase 2

Completed

• Conditions: Leiomyoma
• Interventions: Drug: Asoprisnil

• Registration Number: NCT00156182
• Lead Sponsor: Abbott

Brief Summary

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Detailed Description

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Status Verified: 2008-05
• Last Update Submitted: 2009-03-03
• Last Update Posted: 2009-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Completed dosing and Day 84 procedures at sites in study M99-144
• No interruption of dosing
• Otherwise continued good health

Exclusion Criteria

• Any abnormal lab result the study-doctor considers significant
• History of severe reaction to or current use of hormone therapy
• History of alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Asoprisnil	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144	Treatment months 3 and 6 and Post-treatment months 3 and 6
Percentage of subjects that achieved amenorrhea.	Treatment months 1-6

Secondary Outcome Measures

Name	Time	Method
Improvement in hematologic parameters.	Treatment months 2,4,and 6
Change from baseline in uterine size in gestational weeks.	Months 3 and 6
Mean change from baseline for endocrine determinations.	Months 2,4 and 6
Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale	Treatment Months 1-6
Duration of amenorrhea.	Start of previous study to first post-treatment menses.
Response to global efficacy question regarding improvement of fibroid symptoms.	Month 6