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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00160381 |
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 |
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Leiomyoma Menorrhagia Metrorrhagia |
Drug: Asoprisnil Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata. |
Enrollment: | 432 |
Study Start Date: | September 2002 |
Study Completion Date: | January 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Asoprisnil
10mg Tablet, oral Daily for 12 months
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2: Experimental |
Drug: Asoprisnil
25 mg Tablet, oral Daily for 12 months
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3: Placebo Comparator |
Drug: Placebo
Tablet, oral Daily for 12 months
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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 older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Cynthia Mattia-Goldberg ) |
Study ID Numbers: | M01-394 |
Study First Received: | September 8, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00160381 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
Symptomatic Uterine Fibroids Excessive Uterine Bleeding Uterine Hemorrhage asoprisnil |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Myofibroma Menstruation Disturbances Metrorrhagia Uterine Hemorrhage |
Connective Tissue Diseases Uterine Diseases Menorrhagia Hemorrhage Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Pathologic Processes Neoplasms by Histologic Type Neoplasms, Connective Tissue |