A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
18 Years
N/A
Female
Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
Trial Information
A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata
who completed the 6 month Study C02-037. The safety endpoints for this study will be based
on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and
clinical laboratory evaluations.
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.
Inclusion Criteria:
- Women that have completed 6 months of treatment in study C02-037 with no more than a
7-day interruption in their treatment
- Otherwise good health
- Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
- Agrees to double-barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
Exclusion Criteria:
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in
either a cure or made the symptoms go away
- Significant gynecological disorder, such as endometrial polyp
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Long Term Safety
Outcome Time Frame:
Throughout 18 month treatment period
Safety Issue:
Yes
Principal Investigator
Medical Director
Investigator Role:
Study Chair
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
C03-062
NCT ID:
NCT00156208
Start Date:
April 2004
Completion Date:
December 2006
Related Keywords:
- Fibroid Uterus
- Leiomyoma
- Menorrhagia
- Metrorrhagia
- Uterine Fibroids
- Symptomatic Uterine Fibroids
- Excessive Uterine Bleeding
- Uterine Hemorrhage
- asoprisnil
- Leiomyoma
- Myofibroma
- Menorrhagia
- Metrorrhagia
Name | Location |
|---|
