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Study of Asoprisnil in the Treatment of Uterine Fibroids.

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

Eligibility Criteria

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

Inclusion Criteria: Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment Otherwise in good health Premenopausal based on Estrogen and FSH levels Adequate endometrial biopsy with no significant histological disorder Agrees to use double-barrier method of contraception Exclusion Criteria: Any abnormal lab or procedure result(s) the study-doctor considers important History of a blood-clotting disorder History of osteoporosis requiring treatment Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study Hemoglobin < 8.0 g/dL Endometrial thickness ≥ 19 mm

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

    Change from baseline in the monthly bleeding score and the number of days with bleeding.
    Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
    Percent change from baseline in volume of the largest fibroid.
    Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
    Change from baseline in the 8 scales of the SF-36 questionnaire.
    Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.
    Cumulative percent of subjects who achieve amenorrhea.

    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
    NCT00156156
    Brief Title
    Study of Asoprisnil in the Treatment of Uterine Fibroids.
    Official Title
    A Phase 3, Continuation Study to Evaluate the Long-Term 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
    November 2004 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (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 abnormal uterine bleeding associated with uterine fibroids.
    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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab 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.

    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
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    149 (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
    Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Other Intervention Name(s)
    J867
    Intervention Description
    Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
    Primary Outcome Measure Information:
    Title
    Long-term Safety.
    Time Frame
    Throughout 2 year treatment period
    Secondary Outcome Measure Information:
    Title
    Change from baseline in the monthly bleeding score and the number of days with bleeding.
    Time Frame
    Each Month
    Title
    Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
    Time Frame
    Months 3, 6, 9,12,15,18, 24
    Title
    Percent change from baseline in volume of the largest fibroid.
    Time Frame
    Months 12, 24
    Title
    Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
    Time Frame
    Months 6, 12, 18, 24
    Title
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
    Time Frame
    Months 6, 12, 18, 24
    Title
    Change from baseline in the 8 scales of the SF-36 questionnaire.
    Time Frame
    Months 6, 12, 18, 24
    Title
    Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.
    Time Frame
    Months 6, 12, 18, 24
    Title
    Cumulative percent of subjects who achieve amenorrhea.
    Time Frame
    Each Month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment Otherwise in good health Premenopausal based on Estrogen and FSH levels Adequate endometrial biopsy with no significant histological disorder Agrees to use double-barrier method of contraception Exclusion Criteria: Any abnormal lab or procedure result(s) the study-doctor considers important History of a blood-clotting disorder History of osteoporosis requiring treatment Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study Hemoglobin < 8.0 g/dL Endometrial thickness ≥ 19 mm
    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

    Study of Asoprisnil in the Treatment of Uterine Fibroids.

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