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

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

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

Study Overview

• Status: Completed
• Conditions: Metrorrhagia; Leiomyoma; Menorrhagia
• Intervention / Treatment: Drug: Asoprisnil; Drug: Asoprisnil

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 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
• Enrollment (Actual): 523
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Asoprisnil; 25 mg Tablet, oral Daily for 12 months; Drug: Asoprisnil; 10 mg Tablet, oral Daily for 12 months
Experimental: 2	Drug: Asoprisnil; 25 mg Tablet, oral Daily for 12 months; Drug: Asoprisnil; 10 mg Tablet, oral Daily for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.	Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative percent of subjects who achieve amenorrhea.	Each Month
Change from baseline in hemoglobin concentration.	Final Visit
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.	Final Visit
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.	Final Visit
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.	Month 6
Change from baseline in menstrual pictogram bleeding score.	Final Month
Change from baseline in the number of days with bleeding.	Final Month
Percent change from baseline in the volume of the largest fibroid.	Final Visit

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): May 29, 2008
• Last Update Submitted That Met QC Criteria: May 27, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Symptomatic Uterine Fibroids; Excessive Uterine Bleeding; Uterine Hemorrhage; asoprisnil
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Metrorrhagia; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID Numbers: M01-391