Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996603
The ClinicalTrials.gov registry entry for NCT03996603 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 354-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (93% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
RECRUITING · Phase 4
-
Postpartum Vaginal Estrogen for Breastfeeding Patients
RECRUITING · Phase 4
-
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
RECRUITING · Phase 4
-
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
RECRUITING · NA
-
PRP Injections for Genitourinary Syndrome of Menopause
ACTIVE NOT RECRUITING · NA
-
Topical DHEA Against Vaginal Atrophy
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.