Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00156195
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 abnormal uterine bleeding associated with uterine fibroids.


Condition Intervention Phase
Leiomyoma
Menorrhagia
Metrorrhagia
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 3, 12-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:
  • The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from baseline in menstrual pictogram bleeding score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in the number of days with bleeding. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Percent change from baseline in the volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Each Month ] [ Designated as safety issue: No ]

Enrollment: 523
Study Start Date: September 2003
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Asoprisnil
10 mg Tablet, oral Daily for 12 months
Experimental: 2 Drug: Asoprisnil
25 mg Tablet, oral Daily for 12 months

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 tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory 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.

  Eligibility

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

Inclusion Criteria:

  • Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
  • Otherwise in good health
  • Premenopausal based on Estrogen and FSH levels
  • Agrees to use of 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
  • Significant gynecological disorder such as confirmed endometrial polyp
  • Hemoglobin < 8.0 g/dL
  • 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.
  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: NCT00156195

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

No publications provided

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00156195     History of Changes
Other Study ID Numbers: M01-391
Study First Received: September 7, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 22, 2014