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Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Primary Purpose

Leiomyoma, Menorrhagia, Metrorrhagia

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 Leiomyoma 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 who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively Otherwise in good health Premenopausal based on Estrogen and FSH levels Agrees to use of 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 Significant gynecological disorder such as confirmed endometrial polyp Hemoglobin < 8.0 g/dL 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.

    Secondary Outcome Measures

    The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
    Change from baseline in menstrual pictogram bleeding score.
    Change from baseline in the number of days with bleeding.
    Change from baseline in hemoglobin concentration.
    Percent change from baseline in the 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 Symptom-Quality of Life total score.
    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
    NCT00156195
    Brief Title
    Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
    Official Title
    A Phase 3, 12-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
    September 2003 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (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 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 asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory 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
    Leiomyoma, Menorrhagia, Metrorrhagia
    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
    523 (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
    Intervention Description
    10 mg Tablet, oral Daily for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Intervention Description
    25 mg Tablet, oral Daily for 12 months
    Primary Outcome Measure Information:
    Title
    The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
    Time Frame
    Month 12
    Secondary Outcome Measure Information:
    Title
    The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
    Time Frame
    Month 6
    Title
    Change from baseline in menstrual pictogram bleeding score.
    Time Frame
    Final Month
    Title
    Change from baseline in the number of days with bleeding.
    Time Frame
    Final Month
    Title
    Change from baseline in hemoglobin concentration.
    Time Frame
    Final Visit
    Title
    Percent change from baseline in the volume of the largest fibroid.
    Time Frame
    Final Visit
    Title
    Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
    Time Frame
    Final Visit
    Title
    Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
    Time Frame
    Final Visit
    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 treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively Otherwise in good health Premenopausal based on Estrogen and FSH levels Agrees to use of 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 Significant gynecological disorder such as confirmed endometrial polyp Hemoglobin < 8.0 g/dL 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Abbott
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31777761
    Citation
    Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019.
    Results Reference
    derived

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    Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

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