The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
Timeframe: From enrollment to after 3 months after the end of treatment
evaluation of vulvovaginal and urinary symptoms
Timeframe: 6 months
improvement in vaginal signs
Timeframe: 6 months
evaluation fo maturation index
Timeframe: 6 months
grade of satisfaction
Timeframe: 6 months