Status:
COMPLETED
Treatment of Uterine Fibroids With Asoprisnil(J867)
Lead Sponsor:
Abbott
Conditions:
Leiomyoma
Menorrhagia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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.
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 objec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT00152269
Start Date
July 1 2002
End Date
January 1 2005
Last Update
May 29 2008
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