Study of Asoprisnil in the Treatment of Uterine Fibroids.
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|ClinicalTrials.gov Identifier: NCT00156156|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids||Drug: Asoprisnil||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata|
|Study Start Date :||November 2004|
|Primary Completion Date :||February 2007|
|Study Completion Date :||February 2007|
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
Other Name: J867
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
Other Name: J867
- Long-term Safety. [ Time Frame: Throughout 2 year treatment period ]
- Change from baseline in the monthly bleeding score and the number of days with bleeding. [ Time Frame: Each Month ]
- Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations. [ Time Frame: Months 3, 6, 9,12,15,18, 24 ]
- Percent change from baseline in volume of the largest fibroid. [ Time Frame: Months 12, 24 ]
- Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Months 6, 12, 18, 24 ]
- Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [ Time Frame: Months 6, 12, 18, 24 ]
- Change from baseline in the 8 scales of the SF-36 questionnaire. [ Time Frame: Months 6, 12, 18, 24 ]
- Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire. [ Time Frame: Months 6, 12, 18, 24 ]
- Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Each Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156156
|Study Chair:||Medical Director||Abbott|