Treatment of Uterine Fibroids With Asoprisnil(J867)

Last updated: May 27, 2008
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Menstrual Disorders

Uterina Myoma

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT00152269
M01-390
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

  • Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the studymedication fails

  • Negative pregnancy test

  • Agrees to Double-barrier method of contraception

  • Pap smear with no evidence of malignancy or pre-malignant changes

  • Endometrial biopsy with no significant histological disorder

Exclusion

Exclusion Criteria:

  • 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

  • Previous myomectomy with 1 year and/or previous uterine artery embolization within 6months

  • History of Polycystic Ovary Syndrome or prolactinoma

  • MRI shows significant gynecologic disorder

  • Uterine size > 25 weeks gestation

  • Hemoglobin < 8 g/dL at Day -1

Study Design

Total Participants: 475
Study Start date:
July 01, 2002
Estimated Completion Date:
January 31, 2005

Study 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.