Not Signed In -
Uterine Fibroids |
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Clinical Trial: A Study to Evaluate the Effects of Asoprisnil in Women with Uterine Fibroids Who Are Scheduled for a Hysterectomy.
This study has been completed.
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Purpose
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.
| Condition | Intervention | Phase |
|---|---|---|
| Uterine Fibroids, Leiomyoma | Drug: Asoprisnil | Phase II |
MedlinePlus related topics: Uterine Fibroids
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: A Phase II, 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
Further Study Details:
Primary Outcomes: Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistence Index (RI) using the mean RI of both sides for each subject
Secondary Outcomes: Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index (PI); morphological changes in the endometrium, myometrium, and uterine fibroids; percent change from baseline in volume of the largest fibroid; etc.
Expected Total Enrollment: 45
Secondary Outcomes: Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index (PI); morphological changes in the endometrium, myometrium, and uterine fibroids; percent change from baseline in volume of the largest fibroid; etc.
Expected Total Enrollment: 45
Study start: July 2003; Study completion: January 2006
Last follow-up: April 2005; Data entry closure: May 2005
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 asprisnil 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
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
Exclusion Criteria:
Location Information
Study chairs or principal investigators
Kristof Chwalisz, MD, PHD, Study Chair, TAP Pharmaceutical Products
More Information
Study ID Numbers: C02-003
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150644
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150644
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- ACOG's Physician Directory (American College of Obstetricians and Gynecologists)
- ClinicalTrials.gov: Leiomyoma (National Institutes of Health)
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