Status:
COMPLETED
A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
Lead Sponsor:
Abbott
Conditions:
Uterine Fibroids
Leiomyoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometriu...
Detailed Description
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. ...
Eligibility Criteria
Inclusion
- Premenopausal women, at least 18 years of age
- Diagnosis of uterine fibroid(s), confirmed by ultrasound
- History of menstrual cycles between 17 and 42 days
- Otherwise in good health
- Scheduled for a hysterectomy at the end of the treatment period
- Negative pregnancy test
- Agrees to double barrier method of contraception
- Pap test with no evidence of malignancy or pre-malignant changes
- Endometrial biopsy with no significant histological disorder
Exclusion
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of cancer or alcohol or drug abuse
- Diagnosis of Polycystic Ovary Syndrome
- History of prolactinoma
- Current use of Intrauterine Device
- Significant gynecological disorder
- Uterine size \> 32 weeks gestation
- Current diagnosis of endometriosis
- Uterine artery embolization within 6 months
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00150644
Start Date
July 1 2003
End Date
May 1 2005
Last Update
May 29 2008
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