A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Study Overview

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

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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

• Study Type: Interventional
• Enrollment (Actual): 432
• 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:

• Premenopausal women
• History of regular menstrual cycles (21-42 days)
• Diagnosis of uterine fibroid(s)
• Abnormal vaginal bleeding associated with uterine fibroids
• Otherwise in good health
• Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
• Negative pregnancy test
• Agrees to Double-barrier method of contraception
• Pap smear with no evidence of malignancy or pre-malignant changes
• Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

• Any abnormal lab or procedure result the study-doctor considers important
• Severe reaction(s) to or are currently using any hormone therapy
• History of osteoporosis or other bone disease
• Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
• History of Polycystic Ovary Syndrome or prolactinoma
• MRI shows significant gynecologic disorder
• Uterine size > 25 weeks gestation
• Hemoglobin < 8 g/dL at Day -1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: Asoprisnil; 10mg Tablet, oral Daily for 12 months; Drug: Asoprisnil; 25 mg Tablet, oral Daily for 12 months
EXPERIMENTAL: 2	Drug: Asoprisnil; 10mg Tablet, oral Daily for 12 months; Drug: Asoprisnil; 25 mg Tablet, oral Daily for 12 months
PLACEBO_COMPARATOR: 3	Drug: Placebo; 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 who do not require surgical/invasive intervention.	Month 12 or Final Visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in volume of the largest fibroid.	Final Visit
Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.	Month 6
Change from baseline in menstrual pictogram score.	Final Month
Change from baseline in number of days with bleeding.	Final 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 UFS-QOL total score.	Final Visit
Cumulative percent of subjects who achieve amenorrhea.	Month 3

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.
• Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (ACTUAL): January 1, 2005
• Study Completion (ACTUAL): January 1, 2005

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 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: M01-394