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Asoprisnil

Medical Director

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.

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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Safety of Treatment of Uterine Fibroids With Asoprisnil

A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Abbott

Cynthia Mattia-Goldberg

Asoprisnil 10 mg Tablet, oral Daily for 6 months

Asoprisnil 25mg Tablet, oral Daily for 6 months

Placebo

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 premenopausal subjects with symptomatic uterine leiomyomata.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

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

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Asoprisnil 10 mg Tablet, oral Daily for up to 2 years

Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Study of Asoprisnil in the Treatment of Uterine Fibroids.

A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata

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.

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.

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

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Treatment of Uterine Fibroids With Asoprisnil	NCT00156208	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
Safety of Treatment of Uterine Fibroids With Asoprisnil	NCT00156208	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids	NCT00152256	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil Placebo	18 Years - 53 Years	Abbott
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids	NCT00156195	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil	18 Years -	Abbott
Study of Asoprisnil in the Treatment of Uterine Fibroids.	NCT00156156	Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroid...	Asoprisnil Asoprisnil	18 Years -	Abbott
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids	NCT00156195	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil	18 Years -	Abbott
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids	NCT00160381	Leiomyoma Menorrhagia Metrorrhagia	Asoprisnil Asoprisnil Placebo	18 Years -	Abbott

Spots Global Cancer Trial Database for excessive uterine bleeding