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

Primary Purpose

Fibroid Uterus, Leiomyoma, Menorrhagia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asoprisnil
Asoprisnil
Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibroid Uterus focused on measuring Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage

Eligibility Criteria

18 Years - 53 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cumulative percent of subjects achieving amenorrhea.

    Secondary Outcome Measures

    Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
    Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
    Change from baseline in the Work Limitation Questionnaire Index.
    Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
    Change from baseline in the monthly bleeding score.
    Change from baseline in the hemoglobin concentration.
    Change from baseline in volume of the largest fibroid.
    Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.
    Percentage of subjects who respond positively to the global efficacy question.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    May 27, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00152256
    Brief Title
    A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    February 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
    Keywords
    Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    239 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Other Intervention Name(s)
    J867
    Intervention Description
    Asoprisnil 10 mg Tablet, oral Daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Other Intervention Name(s)
    J867
    Intervention Description
    Asoprisnil 25mg Tablet, oral Daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo Tablet, oral Daily for 6 months
    Primary Outcome Measure Information:
    Title
    Cumulative percent of subjects achieving amenorrhea.
    Time Frame
    Month 3
    Secondary Outcome Measure Information:
    Title
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
    Time Frame
    Final Visit
    Title
    Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
    Time Frame
    Final Visit
    Title
    Change from baseline in the Work Limitation Questionnaire Index.
    Time Frame
    Final Visit
    Title
    Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
    Time Frame
    Final Visit
    Title
    Change from baseline in the monthly bleeding score.
    Time Frame
    Final Visit
    Title
    Change from baseline in the hemoglobin concentration.
    Time Frame
    Final Visit
    Title
    Change from baseline in volume of the largest fibroid.
    Time Frame
    Final Visit
    Title
    Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.
    Time Frame
    During treatment period
    Title
    Percentage of subjects who respond positively to the global efficacy question.
    Time Frame
    Final Visit

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    53 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Abbott
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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