Clinical trial NCT03740945: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Vaginal Atrophy in Breast Cancer Patients
Keywords: Vulvovaginal atrophy (VVA)
Vaginal atrophy
Atrophic vaginitis
Prasterone
DHEA
Intrarosa
Breast cancer
Aromatase inhibitor
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2018-11-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline to Week 12 in the Percentage of Superficial Cells
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in the Percentage of Parabasal Cells
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in Vaginal pH
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 on arousal/lubrication domain of Female Sexual Function Index (FSFI) questionnaire
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 on subjective arousal domain of FSFI
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 on desire domain of FSFI
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 on satisfaction domain of FSFI
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 on orgasm domain of FSFI
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Endoceutics, Inc., Quebec, Canada
name: Claude Labrie, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Jones Institute, Norfolk VA 23507
name: David F Archer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MacDonald Women's Hospital, Cleveland, OH 44106 USA
name: Sheryl Kingsberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.