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NCT03996603 · ClinicalTrials.gov registry record · Phase 4
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
A Phase 4 study of Vaginal Atrophy and Postmenopausal Symptoms, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03996603: Completed Phase 4 study of Vaginal Atrophy and Postmenopausal Symptoms, sponsored by University of Alabama at Birmingham.
NCT03996603 is a Phase 4 study of Vaginal Atrophy and Postmenopausal Symptoms that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants, below the 354-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996603, a Phase 4 study of Vaginal Atrophy and Postmenopausal Symptoms, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1. The quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified sta
Conditions Studied
Interventions
- DRUG Conjugated Estrogens Cream
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2021-01-14 |
| Phase | Phase 4 |
What the finished NCT03996603 record still lists
NCT03996603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 354-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Vaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which Conjugated Estrogens Cream is the first listed.
NCT03996603 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT03996603 about?
NCT03996603 is a clinical study titled "Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy". 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 composit...
What is the current status of trial NCT03996603?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2019-08-01. Estimated completion is 2021-01-14.
What conditions does trial NCT03996603 study?
This clinical trial studies the following conditions: Vaginal Atrophy, Postmenopausal Symptoms, Female Urogenital Diseases, Postmenopausal Atrophic Vaginitis, Genitourinary Disease.
What interventions are being tested in trial NCT03996603?
The interventions under investigation include: Conjugated Estrogens Cream (DRUG).
Who is sponsoring clinical trial NCT03996603?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03996603 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vaginal Atrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03996603's enrollment target sits among peer trials
25 8th of 9 higher than 2 of 9 other Vaginal Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vaginal Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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