Not Signed In -
Uterine Fibroids |
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Clinical Trial: A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Abnormal Uterine Bleeding in Women with Uterine Fibroids
This study is no longer recruiting patients.
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Purpose
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
| Condition | Intervention | Phase |
|---|---|---|
| Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids | Drug: Asoprisnil | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title: A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects with Uterine Leiomyomata
Further Study Details:
Primary Outcomes: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention during the treatment period or who discontinue treatment because of planned surgical/invasive intervention
Secondary Outcomes: Secondary outcomes in this study will assess improvement in bleeding symptoms associated with uterine fibroids in symptomatic women and their quality-of-life.
Expected Total Enrollment: 150
Secondary Outcomes: Secondary outcomes in this study will assess improvement in bleeding symptoms associated with uterine fibroids in symptomatic women and their quality-of-life.
Expected Total Enrollment: 150
Study start: September 2003; Study completion: July 2006
Last follow-up: August 2005; Data entry closure: September 2005
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- Otherwise in good health
- Agree to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails.
Exclusion Criteria:
Location Information
Study chairs or principal investigators
Kristof Chwalisz, MD, PhD, Study Chair, TAP Pharmaceutical Products
More Information
Study ID Numbers: M01-391
Last Updated: September 9, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00156195
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: NCT00156195
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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