Treatment of Uterine Fibroids With Asoprisnil(J867)
Summary
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
Description
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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Leiomyoma
Intervention
Asoprisnil, Asoprisnil, Placebo
Status
Completed
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00152269
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Myofibromatosis
A condition characterized by multiple formations of myofibromas (LEIOMYOMA).
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Gastrointestinal Stromal Tumors
All tumors in the GASTROINTESTINAL TRACT arising from mesenchymal cells (MESODERM) except those of smooth muscle cells (LEIOMYOMA) or Schwann cells (SCHWANNOMA).
Leiomyoma, Epithelioid
A relatively rare smooth muscle tumor found most frequently in the wall of the gastrointestinal tract, especially in the stomach. It is similar to other smooth muscle tumors but may become very large and hemorrhage and exhibit small cystic areas. Simple excision is almost always curative. (From Dorland, 27th ed; DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1354)
Clinical Trials
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
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.
The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to preme...
Study of Asoprisnil in the Treatment of Uterine Fibroids.
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
Safety of Treatment of Uterine Fibroids With Asoprisnil
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
PubMed Articles
Primary Leiomyoma of the pleura.
ABSTRACT: Primary leiomyoma of the pleura is extremely rare. A 45-year-old man presented with a complaint of right chest pain. Chest computed tomography demonstrated a solid, round pleural mass in the...
In order not to over treat uterine leiomyoma and to avoid overlooking uterine leiomyosarcoma, a highly reliable diagnostic method has been thought. Occasionally, it is difficult to discriminate uterin...
Fistula between degenerated uterine leiomyoma and the bladder: case report.
Most common reason for the vesicouterine fistula is a cesarean section; no cases were reported of degenerated uterine leiomyoma communicating with the urinary bladder. We report a case of fistulous co...
Real Anal Leiomyoma: a Case Report.
Leiomyoma of the rectum and anal canal is an unusual benign mesenchymal neoplasm that originates from smooth muscle cells. We describe the clinical presentation, MRI findings, and surgical treatment o...
T-cadherin expression in uterine leiomyoma.
OBJECTIVE: T-cadherin is a tumor-suppressor with low expression in many malignant tumors, but with high expression in endothelial cells and so on. In this study we investigated whether T-cadherin was...
