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Withdrawn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
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
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
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
NCT ID
NCT03740945
First Posted
November 7, 2018
Last Updated
July 29, 2020
Sponsor
EndoCeutics Inc.
Collaborators
AMAG Pharmaceuticals, Inc.
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
Learn more about this trial
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
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