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

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: NCT00152256
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 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.

Condition or disease Intervention/treatment Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids 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. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for 6 months
Other Name: J867
Experimental: 2 Drug: Asoprisnil
Asoprisnil 25mg Tablet, oral Daily for 6 months
Other Name: J867
Placebo Comparator: 3 Drug: Placebo
Placebo Tablet, oral Daily for 6 months

Primary Outcome Measures :
  1. Cumulative percent of subjects achieving amenorrhea. [ Time Frame: Month 3 ]

Secondary Outcome Measures :
  1. Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. [ Time Frame: Final Visit ]
  2. Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. [ Time Frame: Final Visit ]
  3. Change from baseline in the Work Limitation Questionnaire Index. [ Time Frame: Final Visit ]
  4. Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary). [ Time Frame: Final Visit ]
  5. Change from baseline in the monthly bleeding score. [ Time Frame: Final Visit ]
  6. Change from baseline in the hemoglobin concentration. [ Time Frame: Final Visit ]
  7. Change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ]
  8. Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment. [ Time Frame: During treatment period ]
  9. Percentage of subjects who respond positively to the global efficacy question. [ Time Frame: Final Visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 53 Years   (Adult)
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
  • 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

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): NCT00152256

Sponsors and Collaborators
Study Chair: Medical Director Abbott

Responsible Party: Cynthia Mattia-Goldberg, Abbott Identifier: NCT00152256     History of Changes
Other Study ID Numbers: C02-037
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