A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
18 Years
N/A
Female
Uterine Fibroids, Leiomyoma
Trial Information
A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
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. Full thickness biopsies obtained from surgical procedures will allow
the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial
angiogenesis. Various other exploratory immunohistological and biochemical specimens will
be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the
myometrium, and in uterine fibroids.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Outcome Time Frame:
Final visit
Safety Issue:
No
Principal Investigator
Medical Director
Investigator Role:
Study Chair
Investigator Affiliation:
Abbott
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
C02-003
NCT ID:
NCT00150644
Start Date:
July 2003
Completion Date:
May 2005
Related Keywords:
- Uterine Fibroids
- Leiomyoma
- Fibroid Uterus
- Leiomyoma
- Uterine Fibroids
- Hysterectomy
- Asoprisnil
- Leiomyoma
- Myofibroma
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