Safety of Treatment of Uterine Fibroids With Asoprisnil

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

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.

Study Overview

• Status: Completed
• Conditions: Metrorrhagia; Leiomyoma; Uterine Fibroids; Menorrhagia; Fibroid Uterus
• Intervention / Treatment: Drug: Asoprisnil; Drug: Asoprisnil

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 Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long Term Safety	Throughout 18 month treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): May 29, 2008
• Last Update Submitted That Met QC Criteria: May 27, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Symptomatic Uterine Fibroids; Excessive Uterine Bleeding; Uterine Hemorrhage; asoprisnil
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Metrorrhagia; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID Numbers: C03-062