Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Abbott523 enrolled

Overview

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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 tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory 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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

523

Conditions

Leiomyoma Menorrhagia Metrorrhagia

Interventions

AsoprisnilDRUG

10 mg Tablet, oral Daily for 12 months

AsoprisnilDRUG

25 mg Tablet, oral Daily for 12 months

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively * Otherwise in good health * Premenopausal based on Estrogen and FSH levels * Agrees to use of 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 * Significant gynecological disorder such as confirmed endometrial polyp * Hemoglobin \< 8.0 g/dL * 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.

Outcomes

Primary Outcomes

The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.

Time frame: Month 12

Secondary Outcomes

The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.

Time frame: Month 6

Change from baseline in menstrual pictogram bleeding score.

Time frame: Final Month

Change from baseline in the number of days with bleeding.

Time frame: Final Month

Change from baseline in hemoglobin concentration.

Time frame: Final Visit

Percent change from baseline in the volume of the largest fibroid.

Time frame: Final Visit

Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.

Time frame: Final Visit

Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.

Time frame: Final Visit

Cumulative percent of subjects who achieve amenorrhea.

Time frame: Each Month

Data from ClinicalTrials.gov

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