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A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

2014-07-23 21:48:43 | BioPortfolio

Summary

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.

Description

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

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, Asoprisnil, Placebo

Status

Completed

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:43-0400

Clinical Trials [43 Associated Clinical Trials listed on BioPortfolio]

Treatment of Uterine Fibroids With Asoprisnil(J867)

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.

A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis.

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.

A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

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 [935 Associated PubMed Articles listed on BioPortfolio]

Investigating the loss of work productivity due to symptomatic leiomyoma.

Leiomyoma affects up to 50% of fertile women, leading to morbidity such as bleeding or pain. The effect of symptomatic leiomyoma on the productivity of employed women is understudied. The present stud...

Size of uterine leiomyoma is a predictor for massive haemorrhage during caesarean delivery.

Uterine leiomyoma is a common benign tumour, and a risk factor for various complications during pregnancy and peripartum period. Peripartum haemorrhage is the most critical complication that can cause...

Concurrent benign metastasizing leiomyoma in the lung and lumbar spine with elevated standardized uptake value level in positron-emission tomography computed tomography: A case report and literature review.

Benign metastasizing leiomyoma (BML) is rare condition involving distant metastases secondary to benign uterine leiomyoma, and it is most commonly found in the lungs. It rarely metastasizes to the spi...

Submucosal tunneling endoscopic resection of a gigantic cardiac leiomyoma.

Submucosal tunneling endoscopic resection (STER) has been demonstrated to be effective and safe to remove gastrointestinal stromal tumor or leiomyoma .We showed the submucosal tunneling technique for ...

The Rare Togetherness of Bladder Leiomyoma and Neurofibromatosis.

Neurofibromatosis Type 1 (Von Recklinghausen disease) is a common, autosomal dominant hereditary disorder characterized by involvement of multiple tissues derived from the neural crest. Urinary system...

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Surgical removal of a LEIOMYOMA of the UTERUS.

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.

A condition characterized by multiple formations of myofibromas (LEIOMYOMA).

All tumors in the GASTROINTESTINAL TRACT arising from mesenchymal cells (MESODERM) except those of smooth muscle cells (LEIOMYOMA) or Schwann cells (SCHWANNOMA).

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