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

• Status: Completed
• Trial end date: 2021-01-14
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• Postmenopausal with vulvovaginal atrophy

• Age ≥55 years old and a screening vaginal pH of ≥5.

• Without menses for ≥12 months.

• No uterovaginal or vaginal vault prolapse beyond the hymen.

• No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)

Exclusion Criteria:

• Patients with BMI >35kg/m2

• Any patients with infections requiring antibiotic or antifungal therapy during the study period.

• Study patients may not use any vaginal suppositories, douches, or vaginal hygiene wipes within the month preceding enrollment. For patients already on hormone therapy, will be allowed to undergo a "wash out" period of estrogen or progesterone products for one month prior to enrollment.

• Additional exclusions included patients with systemic conditions requiring immunosuppressive drugs, currently receiving chemotherapy, or history of pelvic radiation.

• Any patients with contraindications to vaginal estrogen therapy including: vaginal bleeding of unknown etiology; known, suspected, or history of breast cancer or estrogen-dependent neoplasia; active DVT, PE, or h/o these conditions; active arterial thromboembolic disease (ie. stroke or MI) or h/o of these; known liver disease or thrombophilic disorders.

• Current tobacco use.

• Allergy to Premarin® or its constituents.

• Concurrent use of steroid creams for other indications (ie. lichen sclerosis)