NCT02887885

Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women

Detailed description

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.

Conditions

• Atrophy of Vagina
• Postmenopause

Interventions

Type	Name	Description
DRUG	Gynoflor	1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks

Timeline

• Start date: 2018-01-22
• Primary completion: 2020-03-19
• Completion: 2020-04-10
• First posted: 2016-09-02
• Last updated: 2022-04-27

Locations

1 site across 1 country: Switzerland