drugset / Trial / NCT03996603

Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy

NCT03996603

Phase 4 Completed 25 enrolled University of Alabama at Birmingham
Non-randomizedParallel-groupOpen-labelBasic science

Summary

In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.

Timeline

Start
2019-08-01
Primary completion
2021-01-14
Completion
2021-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject conjugated estrogens Other / unclassified 0.625 mg Other