Study of Asoprisnil in the Treatment of Uterine Fibroids.
A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Adequate endometrial biopsy with no significant histological disorder
- Agrees to use double-barrier method of contraception
Exclusion Criteria:
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- History of osteoporosis requiring treatment
- Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
- Hemoglobin < 8.0 g/dL
- Endometrial thickness ≥ 19 mm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
Other Names:
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
Other Names:
|
|
Experimental: 2
|
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
Other Names:
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term Safety.
Time Frame: Throughout 2 year treatment period
|
Throughout 2 year treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in the monthly bleeding score and the number of days with bleeding.
Time Frame: Each Month
|
Each Month
|
|
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
Time Frame: Months 3, 6, 9,12,15,18, 24
|
Months 3, 6, 9,12,15,18, 24
|
|
Percent change from baseline in volume of the largest fibroid.
Time Frame: Months 12, 24
|
Months 12, 24
|
|
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Time Frame: Months 6, 12, 18, 24
|
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
|
Months 6, 12, 18, 24
|
|
Change from baseline in the 8 scales of the SF-36 questionnaire.
Time Frame: Months 6, 12, 18, 24
|
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
|
Months 6, 12, 18, 24
|
|
Cumulative percent of subjects who achieve amenorrhea.
Time Frame: Each Month
|
Each Month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-FB04-078
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