Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women
Within this trial 50 postmenopausal women receive a vaginal estrogen therapy as treatment for symptomatic vaginal atrophy. The sustainability of vaginal estrogen therapy after the end of therapy has not yet been investigated. All participants will be asked to come for the following 7 visits. * Visit 1: Standard Gynecological examination; Inclusion and exclusion criteria check * Visit 2: Handing out of Gynoflor (estrogen) for a 6 weeks treatment. * Visit 3 (Study Start): After using the vaginal estrogen for 6 weeks, a vaginal swap will be done to measure the vaginal maturation index (VMI). The participants will also receive a questionnaire to define some subjective parameters. The parameters measured at visit 1 will count as reference. The estrogen therapy will now be sustained. * Visit 4-6: Measuring of the VMI and handing out the questionnaires to define subjective parameters.
Study Type
OBSERVATIONAL
Enrollment
32
1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
Bern, Switzerland
Mean change in vaginal maturation index (VMI)
Time frame: 0 weeks, 4 weeks
Mean change in VMI
Time frame: 0 weeks,1 week, 2 weeks, 6 weeks
Mean change in vaginal pH
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Number of lactobacilli
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Lactobacillary grade (LBG),
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in the most bothersome moderate and severe symptom of vaginal atrophy (MBS) . The symptoms include dryness, pain/burning sensation, pruritus, discharge, and dyspareunia.
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in health-related quality of life (EQ-5D-5L). Mean change in Female Sexual Function Index (FSFI).
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
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