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

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

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Trial Information

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

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.

Inclusion Criteria:

- Women who have completed 12 months of active treatment in study M01-391 and Month 12
visit procedures Or completed 18 months of active treatment in study C03-062 and
Month 18 visit procedures (with no more than a 14-day interruption in dosing from
study C02-062 and this study) OR could not continue in a previous asoprisnil study,
but are now eligible for retreatment

- Otherwise in good health

- Premenopausal based on Estrogen and FSH levels

- Adequate endometrial biopsy with no significant histological disorder

- Agrees to use double-barrier method of contraception

Exclusion Criteria:

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

- History of a blood-clotting disorder

- History of osteoporosis requiring treatment

- Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or
invasive procedure for uterine fibroids was performed during any previous asoprisnil

- Hemoglobin < 8.0 g/dL

- Endometrial thickness ≥ 19 mm

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Long-term Safety.

Outcome Time Frame:

Throughout 2 year treatment period

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

February 2007

Related Keywords:

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