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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00156195 |
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 |
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Leiomyoma Menorrhagia Metrorrhagia |
Drug: Asoprisnil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata |
Enrollment: | 523 |
Study Start Date: | September 2003 |
Study Completion Date: | January 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Asoprisnil
10 mg 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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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 asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
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: | M01-391 |
Study First Received: | September 7, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00156195 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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 |