Phase 4
N=25
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
Female Urogenital Diseases · Vaginal Atrophy · Postmenopausal Atrophic Vaginitis · Genitourinary Disease · Postmenopausal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT03996603 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina — 0.07; 0.09; 0.12; 0.04 Relative abundance
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Conjugated Estrogens Cream (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina |
0.07; 0.09; 0.12; 0.04 | — |
| SECONDARY Change in Vaginal Maturation Index (VMI) |
35; 42.5; 60; 47.5 | — |
| SECONDARY Change in Vaginal pH |
7.25; 7; 5; 7 | — |
| SECONDARY Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF |
44.4; 132.9; 10.8; 373.6; 10.0; 18.1 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03996603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.