Treatment of Uterine Fibroids With Asoprisnil(J867)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
475 participants in 3 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal