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Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Primary Purpose

Vaginal Atrophy in Breast Cancer Patients

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Prasterone (DHEA)
Sponsored by
EndoCeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Atrophy in Breast Cancer Patients focused on measuring Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Main criteria:

  1. Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study.
  2. Women between 30 and 80 years of age
  3. Women having ≤5% of superficial cells on vaginal smear at baseline
  4. Women having a vaginal pH above 5 at baseline
  5. Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

Exclusion Criteria:

Main criteria:

  1. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
  2. The administration of any investigational drug within 30 days of screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Prasterone

    Arm Description

    Placebo vaginal ovule daily for 12 weeks

    Prasterone (DHEA) vaginal ovule daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Change from Baseline to Week 12 in the Percentage of Superficial Cells
    Change from Baseline to Week 12 in the Percentage of Parabasal Cells
    Change from Baseline to Week 12 in Vaginal pH
    Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)

    Secondary Outcome Measures

    Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
    Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Change from Baseline to Week 12 on subjective arousal domain of FSFI
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Change from Baseline to Week 12 on desire domain of FSFI
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Change from Baseline to Week 12 on satisfaction domain of FSFI
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Change from Baseline to Week 12 on orgasm domain of FSFI
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.

    Full Information

    First Posted
    November 7, 2018
    Last Updated
    July 29, 2020
    Sponsor
    EndoCeutics Inc.
    Collaborators
    AMAG Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03740945
    Brief Title
    Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
    Official Title
    Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision to not perform this study.
    Study Start Date
    November 6, 2018 (Actual)
    Primary Completion Date
    December 5, 2019 (Actual)
    Study Completion Date
    December 5, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EndoCeutics Inc.
    Collaborators
    AMAG Pharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Atrophy in Breast Cancer Patients
    Keywords
    Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, Prasterone, DHEA, Intrarosa, Breast cancer, Aromatase inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo vaginal ovule daily for 12 weeks
    Arm Title
    Prasterone
    Arm Type
    Experimental
    Arm Description
    Prasterone (DHEA) vaginal ovule daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Daily administration of one placebo vaginal ovule at bedtime
    Intervention Type
    Drug
    Intervention Name(s)
    Prasterone (DHEA)
    Other Intervention Name(s)
    Intrarosa
    Intervention Description
    Daily administration of one prasterone vaginal ovule at bedtime
    Primary Outcome Measure Information:
    Title
    Change from Baseline to Week 12 in the Percentage of Superficial Cells
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 in the Percentage of Parabasal Cells
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 in Vaginal pH
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire
    Description
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 on subjective arousal domain of FSFI
    Description
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 on desire domain of FSFI
    Description
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 on satisfaction domain of FSFI
    Description
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Time Frame
    12 weeks
    Title
    Change from Baseline to Week 12 on orgasm domain of FSFI
    Description
    Individual domain score will be obtained by adding the scores of the individual questions that comprise the domain and multiplying the sum by the domain factor.
    Time Frame
    12 weeks
    Title
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
    Description
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Time Frame
    12 weeks
    Title
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
    Description
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Time Frame
    12 weeks
    Title
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
    Description
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Time Frame
    12 weeks
    Title
    Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
    Description
    Vaginal parameter evaluated at gynecological examination by the physician/gynecologist will be graded as corresponding to none, mild, moderate, or severe atrophy.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Main criteria: Natural, surgically- or treatment-induced postmenopausal women (non hysterectomized or hysterectomized) with breast cancer (stage 1 or 2) who is currently under treatment with an aromatase inhibitor and will remain on that treatment for the duration of the study. Women between 30 and 80 years of age Women having ≤5% of superficial cells on vaginal smear at baseline Women having a vaginal pH above 5 at baseline Women who have self-identified moderate or severe symptom(s) of vaginal atrophy Exclusion Criteria: Main criteria: Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication The administration of any investigational drug within 30 days of screening visit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claude Labrie, M.D., Ph.D.
    Organizational Affiliation
    Endoceutics, Inc., Quebec, Canada
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    David F Archer, M.D.
    Organizational Affiliation
    Jones Institute, Norfolk VA 23507
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sheryl Kingsberg, Ph.D.
    Organizational Affiliation
    MacDonald Women's Hospital, Cleveland, OH 44106 USA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26291918
    Citation
    Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.
    Results Reference
    result
    PubMed Identifier
    26597311
    Citation
    Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
    Results Reference
    result
    PubMed Identifier
    26517756
    Citation
    Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.
    Results Reference
    result
    PubMed Identifier
    26731686
    Citation
    Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
    Results Reference
    result
    PubMed Identifier
    26972555
    Citation
    Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.
    Results Reference
    result
    PubMed Identifier
    26634942
    Citation
    Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.
    Results Reference
    result
    PubMed Identifier
    25734980
    Citation
    Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
    Results Reference
    result
    PubMed Identifier
    28640161
    Citation
    Labrie F, Archer DF, Martel C, Vaillancourt M, Montesino M. Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Menopause. 2017 Nov;24(11):1246-1256. doi: 10.1097/GME.0000000000000910.
    Results Reference
    result

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    Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

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