A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata
No medical therapy is currently available for the long-term treatment of uterine fibroids.
The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily
for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine
fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will
be based on ultrasound and endometrial biopsy results, adverse events, and any changes from
baseline laboratory values and vital signs.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
Treatment months 3 and 6 and Post-treatment months 3 and 6
United States: Food and Drug Administration