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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00156182 |
This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
Condition | Intervention | Phase |
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Leiomyoma |
Drug: Asoprisnil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata |
Enrollment: | 38 |
Study Start Date: | April 2001 |
Study Completion Date: | December 2001 |
Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Asoprisnil
10mg Tablet, oral Daily for 6 months
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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.
Ages Eligible for Study: | 18 Years to 48 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Cynthia Mattia-Goldberg ) |
Study ID Numbers: | M01-275 |
Study First Received: | September 7, 2005 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00156182 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Fibroid Uterus Leiomyoma Uterine Fibroids asoprisnil |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Leiomyoma |
Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neoplasms Myofibroma |
Neoplasms by Histologic Type Connective Tissue Diseases Neoplasms, Connective Tissue Leiomyoma |