Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00156156 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata |
Enrollment: | 149 |
Study Start Date: | November 2004 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
|
2: Experimental |
Drug: Asoprisnil
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
|
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.
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: | A-FB04-078 |
Study First Received: | September 7, 2005 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00156156 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Symptomatic Uterine Fibroids Excessive Uterine Bleeding Uterine Hemorrhage |
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 |