A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Inclusion criteria

• Premenopausal women
• History of regular menstrual cycles (21-42 days)
• Diagnosis of uterine fibroid(s)
• Abnormal vaginal bleeding associated with uterine fibroids
• Otherwise in good health
• Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
• Negative pregnancy test
• Agrees to Double-barrier method of contraception
• Pap smear with no evidence of malignancy or pre-malignant changes
• Endometrial biopsy with no significant histological disorder

Exclusion criteria

• Any abnormal lab or procedure result the study-doctor considers important
• Severe reaction(s) to or are currently using any hormone therapy
• History of osteoporosis or other bone disease
• Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
• History of Polycystic Ovary Syndrome or prolactinoma
• MRI shows significant gynecologic disorder
• Uterine size > 25 weeks gestation
• Hemoglobin < 8 g/dL at Day -1