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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00152256
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Cumulative percent of subjects achieving amenorrhea. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • 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 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 (Physical Component Summary and Mental Component Summary). [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in the monthly bleeding score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in the hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • 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 during treatment. [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
  • Percentage of subjects who respond positively to the global efficacy question. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: September 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 53 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00152256

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

No publications provided

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

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 August 21, 2014