Safety of Treatment of Uterine Fibroids With Asoprisnil

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00156208
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Fibroid Uterus
Leiomyoma
Menorrhagia
Metrorrhagia
Uterine Fibroids
Drug: Asoprisnil
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Long Term Safety [ Time Frame: Throughout 18 month treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cumulative and incremental amenorrhea rates. [ Time Frame: Each month 1-18 ] [ Designated as safety issue: No ]
  • Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in Uterine Fibroid Impact Questionnaire. [ Time Frame: Months 6, 12, 18 ] [ Designated as safety issue: No ]
  • Change from baseline in the Work Limitation Questionnaire Index. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in the two dimensions of the SF-36. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in the monthly bleeding score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in the hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Percentage of subjects who discontinue with the intent to have surgery for fibroids. [ Time Frame: During Treatment Period ] [ Designated as safety issue: No ]
  • Percentage of subjects who responded positively to the Global Efficacy Questions. [ Time Frame: Months 6, 12, 18 ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156208

Sponsors and Collaborators
Abbott
Investigators
Study Chair: Medical Director Abbott
  More Information

No publications provided

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00156208     History of Changes
Other Study ID Numbers: C03-062
Study First Received: September 7, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014