At a glance
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The Vaginal Health Trial - Effects of Vaginal Estradiol Tablet and Moisturizing Gel on Postmenopausal Vaginal Symptoms
In Brief
A Phase 3 clinical trial evaluating Vagifem, Replens, and 2 other interventions for Atrophy of Vagina and 2 related conditions. Completed, enrolled 302 participants across 2 sites.
Detailed Summary
This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
Study Details
Timeline
Interventions
One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
2.5 gm to be applied vaginally every 3 days over 12 weeks.
Dispensed in visually identical bottle and tablet form to Vagifem.
Dispensed in visually identical tube and gel form to Replens.