The objective of this study is to determine the long-term safety of asoprisnil in 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:  150

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

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

Criteria

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
• Agree to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails

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

Study chairs or principal investigators

Kristof Chwalisz, MD, PHD,  Study Chair,  TAP Pharmaceutical Products, Incorporated   

Study ID Numbers:  A-FB04-078
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00156156
Health Authority: United States: Food and Drug Administration; Canada: Health Protection Bureau
ClinicalTrials.gov processed this record on 2005-09-13