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A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

Primary Purpose

Leiomyoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Asoprisnil
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Completed dosing and Day 84 procedures at sites in study M99-144 No interruption of dosing Otherwise continued good health Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to or current use of hormone therapy History of alcohol or drug abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
    Percentage of subjects that achieved amenorrhea.

    Secondary Outcome Measures

    Improvement in hematologic parameters.
    Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale
    Change from baseline in uterine size in gestational weeks.
    Duration of amenorrhea.
    Response to global efficacy question regarding improvement of fibroid symptoms.
    Mean change from baseline for endocrine determinations.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    March 3, 2009
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00156182
    Brief Title
    A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.
    Official Title
    A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    December 2001 (Actual)
    Study Completion Date
    December 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
    Detailed Description
    No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leiomyoma
    Keywords
    Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Intervention Description
    10mg Tablet, oral Daily for 6 months
    Primary Outcome Measure Information:
    Title
    Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
    Time Frame
    Treatment months 3 and 6 and Post-treatment months 3 and 6
    Title
    Percentage of subjects that achieved amenorrhea.
    Time Frame
    Treatment months 1-6
    Secondary Outcome Measure Information:
    Title
    Improvement in hematologic parameters.
    Time Frame
    Treatment months 2,4,and 6
    Title
    Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale
    Time Frame
    Treatment Months 1-6
    Title
    Change from baseline in uterine size in gestational weeks.
    Time Frame
    Months 3 and 6
    Title
    Duration of amenorrhea.
    Time Frame
    Start of previous study to first post-treatment menses.
    Title
    Response to global efficacy question regarding improvement of fibroid symptoms.
    Time Frame
    Month 6
    Title
    Mean change from baseline for endocrine determinations.
    Time Frame
    Months 2,4 and 6

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    48 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completed dosing and Day 84 procedures at sites in study M99-144 No interruption of dosing Otherwise continued good health Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to or current use of hormone therapy History of alcohol or drug abuse
    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 Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

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