Safety of Treatment of Uterine Fibroids With Asoprisnil

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00156208

Collaborator

(none)

166

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

Condition or Disease	Intervention/Treatment	Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids	Drug: Asoprisnil Drug: Asoprisnil	Phase 3

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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

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 Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Asoprisnil 10mg Tablet, oral Daily for 18 months Other Names: J867
Experimental: 2	Drug: Asoprisnil 25 mg Tablet, oral Daily for 18 months Other Names: J867

Arm

Intervention/Treatment

Experimental: 1

Drug: Asoprisnil

10mg Tablet, oral Daily for 18 months

Other Names:

J867

Experimental: 2

Drug: Asoprisnil

25 mg Tablet, oral Daily for 18 months

Other Names:

J867

Outcome Measures

Primary Outcome Measures

Long Term Safety [Throughout 18 month treatment period]

Secondary Outcome Measures

Cumulative and incremental amenorrhea rates. [Each month 1-18]
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [Final Visit]
Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. [Final Visit]
Change from baseline in Uterine Fibroid Impact Questionnaire. [Months 6, 12, 18]
Change from baseline in the Work Limitation Questionnaire Index. [Final Visit]
Change from baseline in the two dimensions of the SF-36. [Final Visit]
Change from baseline in the monthly bleeding score. [Final Month]
Change from baseline in the hemoglobin concentration. [Final Visit]
Percent change from baseline in volume of the largest fibroid. [Final Visit]
Percentage of subjects who discontinue with the intent to have surgery for fibroids. [During Treatment Period]
Percentage of subjects who responded positively to the Global Efficacy Questions. [Months 6, 12, 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
Otherwise good health
Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
Agrees to 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
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
Significant gynecological disorder, such as endometrial polyp