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Study of Asoprisnil in the Treatment of Uterine Fibroids.

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ClinicalTrials.gov Identifier: NCT00156156
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 28, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata
Study Start Date : November 2004
Primary Completion Date : February 2007
Study Completion Date : February 2007

Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
Other Name: J867
Experimental: 2 Drug: Asoprisnil
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
Other Name: J867



Primary Outcome Measures :
  1. Long-term Safety. [ Time Frame: Throughout 2 year treatment period ]

Secondary Outcome Measures :
  1. Change from baseline in the monthly bleeding score and the number of days with bleeding. [ Time Frame: Each Month ]
  2. Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations. [ Time Frame: Months 3, 6, 9,12,15,18, 24 ]
  3. Percent change from baseline in volume of the largest fibroid. [ Time Frame: Months 12, 24 ]
  4. Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Months 6, 12, 18, 24 ]
  5. Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [ Time Frame: Months 6, 12, 18, 24 ]
  6. Change from baseline in the 8 scales of the SF-36 questionnaire. [ Time Frame: Months 6, 12, 18, 24 ]
  7. Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire. [ Time Frame: Months 6, 12, 18, 24 ]
  8. Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Each Month ]


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

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 study
  • Hemoglobin < 8.0 g/dL
  • Endometrial thickness ≥ 19 mm

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 ClinicalTrials.gov identifier (NCT number): NCT00156156


Sponsors and Collaborators
Abbott
Investigators
Study Chair: Medical Director Abbott

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00156156     History of Changes
Other Study ID Numbers: A-FB04-078
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

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

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