Treatment of Uterine Fibroids With Asoprisnil(J867)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152269
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 29, 2008
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Leiomyoma Menorrhagia Metrorrhagia Drug: Asoprisnil Drug: Placebo Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata
Study Start Date : July 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil
10mg Tablet, oral Daily for 12 months
Experimental: 2 Drug: Asoprisnil
25mg Tablet, oral Daily for 12 months
Placebo Comparator: 3 Drug: Placebo
Placebo, Tablet, oral Daily for 12 months

Primary Outcome Measures :
  1. The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention. [ Time Frame: Month 12 or Final Visit ]

Secondary Outcome Measures :
  1. Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. [ Time Frame: Month 6 ]
  2. Change from baseline in menstrual pictogram score. [ Time Frame: Final Month ]
  3. Change from baseline in number of days with bleeding. [ Time Frame: Final Month ]
  4. Change from baseline in hemoglobin concentration. [ Time Frame: Final Visit ]
  5. Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ]
  6. Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Final Visit ]
  7. Change from baseline in total symptom severity score and UFS-QOL total score. [ Time Frame: Final Visit ]
  8. Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Month 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 study medication 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 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 6 months
  • History of Polycystic Ovary Syndrome or prolactinoma
  • MRI shows significant gynecologic disorder
  • Uterine size > 25 weeks gestation
  • Hemoglobin < 8 g/dL at Day -1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152269

Sponsors and Collaborators
Study Chair: Medical Director Abbott

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cynthia Mattia-Goldberg, Abbott Identifier: NCT00152269     History of Changes
Other Study ID Numbers: M01-390
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Abbott:
Symptomatic Uterine Fibroids
Excessive Uterine Bleeding
Uterine Hemorrhage

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes