Safety of Treatment of Uterine Fibroids With Asoprisnil

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: NCT00156208
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 29, 2008
Information provided by:

Brief Summary:
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

Condition or disease Intervention/treatment Phase
Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids Drug: Asoprisnil 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 long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
Study Start Date : April 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil
10mg Tablet, oral Daily for 18 months
Other Name: J867

Experimental: 2 Drug: Asoprisnil
25 mg Tablet, oral Daily for 18 months
Other Name: J867

Primary Outcome Measures :
  1. Long Term Safety [ Time Frame: Throughout 18 month treatment period ]

Secondary Outcome Measures :
  1. Cumulative and incremental amenorrhea rates. [ Time Frame: Each month 1-18 ]
  2. Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [ Time Frame: Final Visit ]
  3. Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. [ Time Frame: Final Visit ]
  4. Change from baseline in Uterine Fibroid Impact Questionnaire. [ Time Frame: Months 6, 12, 18 ]
  5. Change from baseline in the Work Limitation Questionnaire Index. [ Time Frame: Final Visit ]
  6. Change from baseline in the two dimensions of the SF-36. [ Time Frame: Final Visit ]
  7. Change from baseline in the monthly bleeding score. [ Time Frame: Final Month ]
  8. Change from baseline in the hemoglobin concentration. [ Time Frame: Final Visit ]
  9. Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ]
  10. Percentage of subjects who discontinue with the intent to have surgery for fibroids. [ Time Frame: During Treatment Period ]
  11. Percentage of subjects who responded positively to the Global Efficacy Questions. [ Time Frame: Months 6, 12, 18 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
  • Otherwise good health
  • Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
  • Agrees to double-barrier method of contraception
  • Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

  • Any abnormal lab or procedure result(s) the study-doctor considers important
  • History of a blood-clotting disorder
  • Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
  • Significant gynecological disorder, such as endometrial polyp

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): NCT00156208

Sponsors and Collaborators
Study Chair: Medical Director Abbott

Responsible Party: Cynthia Mattia-Goldberg, Abbott Identifier: NCT00156208     History of Changes
Other Study ID Numbers: C03-062
First Posted: September 12, 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