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Safety of Treatment of Uterine Fibroids With Asoprisnil

Primary Purpose

Fibroid Uterus, Leiomyoma, Menorrhagia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asoprisnil
Asoprisnil
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, asoprisnil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Long Term Safety

    Secondary Outcome Measures

    Cumulative and incremental amenorrhea rates.
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
    Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
    Change from baseline in Uterine Fibroid Impact Questionnaire.
    Change from baseline in the Work Limitation Questionnaire Index.
    Change from baseline in the two dimensions of the SF-36.
    Change from baseline in the monthly bleeding score.
    Change from baseline in the hemoglobin concentration.
    Percent change from baseline in volume of the largest fibroid.
    Percentage of subjects who discontinue with the intent to have surgery for fibroids.
    Percentage of subjects who responded positively to the Global Efficacy Questions.

    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
    NCT00156208
    Brief Title
    Safety of Treatment of Uterine Fibroids With Asoprisnil
    Official Title
    A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    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, asoprisnil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    166 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Other Intervention Name(s)
    J867
    Intervention Description
    10mg Tablet, oral Daily for 18 months
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Other Intervention Name(s)
    J867
    Intervention Description
    25 mg Tablet, oral Daily for 18 months
    Primary Outcome Measure Information:
    Title
    Long Term Safety
    Time Frame
    Throughout 18 month treatment period
    Secondary Outcome Measure Information:
    Title
    Cumulative and incremental amenorrhea rates.
    Time Frame
    Each month 1-18
    Title
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-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 Uterine Fibroid Impact Questionnaire.
    Time Frame
    Months 6, 12, 18
    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.
    Time Frame
    Final Visit
    Title
    Change from baseline in the monthly bleeding score.
    Time Frame
    Final Month
    Title
    Change from baseline in the hemoglobin concentration.
    Time Frame
    Final Visit
    Title
    Percent 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.
    Time Frame
    During Treatment Period
    Title
    Percentage of subjects who responded positively to the Global Efficacy Questions.
    Time Frame
    Months 6, 12, 18

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    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

    Safety of Treatment of Uterine Fibroids With Asoprisnil

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