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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


Phase 3
18 Years
53 Years
Not Enrolling
Female
Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids

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Trial Information

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


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.


Inclusion Criteria:



- Premenopausal women

- History of regular menstrual cycles (21-42 days)

- Diagnosis of uterine fibroid(s)

- Abnormal vaginal bleeding associated with uterine fibroids

- Otherwise in good health

- Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small
fibroids with a uterine volume of ≥ 200 cm3

Exclusion Criteria:

- Less than 3 months postpartum and post-lactation

- Previous myomectomy within 1 year

- Any abnormal lab or procedure result the study-doctor considers important

- Severe reaction(s) to or are currently using any hormone therapy

- History of osteoporosis or other bone disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Cumulative percent of subjects achieving amenorrhea.

Outcome Time Frame:

Month 3

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Chair

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

C02-037

NCT ID:

NCT00152256

Start Date:

September 2003

Completion Date:

February 2005

Related Keywords:

  • Fibroid Uterus
  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia
  • Uterine Fibroids
  • Symptomatic Uterine Fibroids
  • Excessive Uterine Bleeding
  • Uterine Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Metrorrhagia

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