Not Signed In -
Uterine Fibroids |
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Clinical Trial: A Study to Evaluate the Safety and Effectiveness of 3 Asoprisnil Doses in the Treatment of Abnormal Uterine Bleeding in Women with Uterine Fibroids
This study has been completed.
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Purpose
This study was designed to determine the safety and effectiveness of 3 asoprisnil, doses, compared to placebo, taken for 12 weeks by women with uterine fibroids.
| Condition | Intervention | Phase |
|---|---|---|
| Uterine Fibroids, Leiomyoma | Drug: Asoprisnil | Phase II |
MedlinePlus related topics: Uterine Fibroids
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients with Uterine Leiomyomata.
Further Study Details:
Primary Outcomes: Percent change from baseline in uterine volume and volume of the largest fibroid.
Secondary Outcomes: Duration of amenorrhea, percentage of bleeding days, and average daily bleeding score and frequency of menorrhagia, metorrhagia, dysmenorrhea, dyspareunia, etc.
Expected Total Enrollment: 120
Secondary Outcomes: Duration of amenorrhea, percentage of bleeding days, and average daily bleeding score and frequency of menorrhagia, metorrhagia, dysmenorrhea, dyspareunia, etc.
Expected Total Enrollment: 120
Study start: May 2000; Study completion: December 2003
Last follow-up: December 2001
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
Eligibility
Ages Eligible for Study: 18 Years - 48 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
Exclusion Criteria:
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
Location Information
Study chairs or principal investigators
Kristof Chwalisz, MD,PhD, Study Chair, TAP Pharmaceutical Products
More Information
Study ID Numbers: M99-144
Last Updated: September 11, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00160459
Health Authority: United States: Food and Drug Administration; Canada: Health Protection Bureau
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 11, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00160459
Health Authority: United States: Food and Drug Administration; Canada: Health Protection Bureau
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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