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Treatment of Uterine Fibroids With Asoprisnil(J867)

Primary Purpose

Leiomyoma, Menorrhagia, Metrorrhagia

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 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: 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 Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails Negative pregnancy test Agrees to Double-barrier method of contraception Pap smear with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: 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 Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months History of Polycystic Ovary Syndrome or prolactinoma MRI shows significant gynecologic disorder Uterine size > 25 weeks gestation Hemoglobin < 8 g/dL at Day -1

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

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

    Secondary Outcome Measures

    Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
    Change from baseline in menstrual pictogram score.
    Change from baseline in number of days with bleeding.
    Change from baseline in hemoglobin concentration.
    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 UFS-QOL 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
    NCT00152269
    Brief Title
    Treatment of Uterine Fibroids With Asoprisnil(J867)
    Official Title
    A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 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
    July 2002 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    January 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 effectiveness of asoprisnil in symptomatic 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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

    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
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    475 (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
    Intervention Description
    10mg Tablet, oral Daily for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil
    Intervention Description
    25mg Tablet, oral Daily for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo, 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 have surgical/invasive intervention.
    Time Frame
    Month 12 or Final Visit
    Secondary Outcome Measure Information:
    Title
    Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
    Time Frame
    Month 6
    Title
    Change from baseline in menstrual pictogram score.
    Time Frame
    Final Month
    Title
    Change from baseline in 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 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 UFS-QOL total score.
    Time Frame
    Final Visit
    Title
    Cumulative percent of subjects who achieve amenorrhea.
    Time Frame
    Month 3

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 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 Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails Negative pregnancy test Agrees to Double-barrier method of contraception Pap smear with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: 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 Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months History of Polycystic Ovary Syndrome or prolactinoma MRI shows significant gynecologic disorder Uterine size > 25 weeks gestation Hemoglobin < 8 g/dL at Day -1
    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
    30865281
    Citation
    Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.
    Results Reference
    derived
    PubMed Identifier
    23188490
    Citation
    Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.
    Results Reference
    derived

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    Treatment of Uterine Fibroids With Asoprisnil(J867)

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