Study of Asoprisnil in the Treatment of Uterine Fibroids.

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

NCT00156156

A-FB04-078

Details and patient eligibility

About

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

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

149 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
Otherwise in good health
Premenopausal based on Estrogen and FSH levels
Adequate endometrial biopsy with no significant histological disorder
Agrees to use double-barrier method of contraception

Exclusion criteria

Any abnormal lab or procedure result(s) the study-doctor considers important
History of a blood-clotting disorder
History of osteoporosis requiring treatment
Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
Hemoglobin < 8.0 g/dL
Endometrial thickness ≥ 19 mm