Not Signed In -
Uterine Fibroids |
|
|
[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]
Clinical Trial: A Long-Term Safety Study of Asoprisnil in the Treatment of Abnormal Uterine Bleeding in Women with Uterine Fibroids from Study M99-144.
This study has been completed.
|
Purpose
This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
| Condition | Intervention | Phase |
|---|---|---|
| Uterine Fibroids, Leiomyoma | Drug: Asoprisnil (J867) | Phase II |
MedlinePlus related topics: Uterine Fibroids
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase 2, Long-Term, Open-Label, Safety Extension Study 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 and hematologic, endocrine, and clinical parameters, etc.
Expected Total Enrollment: 50
Secondary Outcomes: Duration of amenorrhea and hematologic, endocrine, and clinical parameters, etc.
Expected Total Enrollment: 50
Study start: April 2001; Study completion: February 2004
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.
Eligibility
Ages Eligible for Study: 18 Years - 48 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Completed dosing and Day 84 procedures at sites in study M99-144
- No interruption of dosing
- Otherwise continued good health
Exclusion Criteria:
Location Information
Study chairs or principal investigators
Kristof Chwalisz, MD, PhD, Study Chair, TAP Pharmaceutical Products
More Information
Study ID Numbers: M01-275
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00156182
Health Authority: United States: Food and Drug Administration; Canada: Health Protection Bureau
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00156182
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)
email this page
print this page
bookmark this page
feedback on this page
