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

Study Overview
=================
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.

Official Title
-----------------
A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Conditions
-----------------
Leiomyoma

Intervention / Treatment
-----------------
* Drug: Asoprisnil


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Asoprisnil<br>* 10mg Tablet, oral Daily for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hematologic parameters. |  | Treatment 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 | 
| Change from baseline in uterine size in gestational weeks. |  | Months 3 and 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 | 
| Mean change from baseline for endocrine determinations. |  | Months 2,4 and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil