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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Daily administration of one placebo vaginal ovule at bedtime
Daily administration of one prasterone vaginal ovule at bedtime
Change from Baseline to Week 12 in the Percentage of Superficial Cells
Time frame: 12 weeks
Change from Baseline to Week 12 in the Percentage of Parabasal Cells
Time frame: 12 weeks
Change from Baseline to Week 12 in Vaginal pH
Time frame: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom being Most Bothersome (MBS)
Time frame: 12 weeks
Change from Baseline to Week 12 in Moderate/Severe VVA symptom (not most bothersome)
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks