Breast Cancer Female Clinical Trial
Official title:
GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors
The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.
Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be
offered participation in an observational, prospective open label trial. Study duration will
be 6 months.
Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying
the prescreen requirements, the patient's information will be forwarded to the
sub-investigator, who will confirm study eligibility and make the final determination
verifying the diagnosis of GSM. Participants will be using commercially available Replens
applied via prefilled applicator into the vagina and coconut oil applied at the vaginal
introitus and vulva. Both are to be administered by the patient 2 times per week, interval
between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed,
coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual
activity. Patients will record dosing on the Intake Diary. Outcome measures will include:
Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered
at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire
will also be used for sexually active patients at the same time points. This is an
exploratory investigation. A planned paired T test will be applied to analyze the outcome and
regroup after data has been collected on the first 14 patients.
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