Clinical trial NCT00156208: Safety of Treatment of Uterine Fibroids With Asoprisnil
Official title: A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibroid Uterus
Leiomyoma
Menorrhagia
Metrorrhagia
Uterine Fibroids
Keywords: Symptomatic Uterine Fibroids
Excessive Uterine Bleeding
Uterine Hemorrhage
asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Long Term Safety
timeFrame: Throughout 18 month treatment period
Secondary outcomes:
measure: Cumulative and incremental amenorrhea rates.
timeFrame: Each month 1-18
measure: Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
timeFrame: Final Visit
measure: Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
timeFrame: Final Visit
measure: Change from baseline in Uterine Fibroid Impact Questionnaire.
timeFrame: Months 6, 12, 18
measure: Change from baseline in the Work Limitation Questionnaire Index.
timeFrame: Final Visit
measure: Change from baseline in the two dimensions of the SF-36.
timeFrame: Final Visit
measure: Change from baseline in the monthly bleeding score.
timeFrame: Final Month
measure: Change from baseline in the hemoglobin concentration.
timeFrame: Final Visit
measure: Percent change from baseline in volume of the largest fibroid.
timeFrame: Final Visit
measure: Percentage of subjects who discontinue with the intent to have surgery for fibroids.
timeFrame: During Treatment Period
measure: Percentage of subjects who responded positively to the Global Efficacy Questions.
timeFrame: Months 6, 12, 18
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References: