The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Condition	Intervention	Phase
Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids	Drug: Asoprisnil	Phase III

Further Study Details: 

Primary Outcomes: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention during the treatment period or who discontinue treatment because of planned surgical/invasive intervention.
Secondary Outcomes: Secondary outcomes in this study will assess improvement in bleeding symptoms associated with uterine fibroids in symptomatic women and their quality-of-life.
Expected Total Enrollment:  375

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

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

Exclusion Criteria:

• Less than 3 months after having a baby
• Currently breast-feeding
• 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

Study chairs or principal investigators

Kristof Chwalisz, MD, PhD,  Study Chair,  TAP Pharmaceutical Products   

Study ID Numbers:  M01-394
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160381
Health Authority: Canada: Health Protection Bureau:; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13