Safety of Treatment of Uterine Fibroids With Asoprisnil

Abbott

Status and phase

Completed

Phase 3

Conditions

Metrorrhagia

Fibroid Uterus

Uterine Fibroids

Leiomyoma

Menorrhagia

Treatments

Drug: Asoprisnil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00156208

C03-062

Details and patient eligibility

About

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.

Full 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.

Enrollment

166 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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