Safety of Treatment of Uterine Fibroids With Asoprisnil

Abbott166 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

166

Conditions

Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids

Interventions

AsoprisnilDRUG

10mg Tablet, oral Daily for 18 months

AsoprisnilDRUG

25 mg Tablet, oral Daily for 18 months

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Long Term Safety

Time frame: Throughout 18 month treatment period

Secondary Outcomes

Cumulative and incremental amenorrhea rates.

Time frame: Each month 1-18

Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.

Time frame: Final Visit

Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.

Time frame: Final Visit

Change from baseline in Uterine Fibroid Impact Questionnaire.

Time frame: Months 6, 12, 18

Change from baseline in the Work Limitation Questionnaire Index.

Time frame: Final Visit

Change from baseline in the two dimensions of the SF-36.

Time frame: Final Visit

Change from baseline in the monthly bleeding score.

Time frame: Final Month

Change from baseline in the hemoglobin concentration.

Time frame: Final Visit

Percent change from baseline in volume of the largest fibroid.

Time frame: Final Visit

Percentage of subjects who discontinue with the intent to have surgery for fibroids.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.