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NCT02869165 · ClinicalTrials.gov registry record · Phase 4

Vaginal and Urinary Microbiome Trial

A Phase 4 study, sponsored by University of Louisville.

Completed
Registry status
Phase 4
Development phase
110
Enrollment target

NCT02869165: Completed Phase 4 study, sponsored by University of Louisville.

NCT02869165 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02869165, a Phase 4 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 4
Development phase
110 participants
Enrollment target

Study Summary

A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause.

Primary Outcome

Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population compared between conjugated equine estrogen cream (Premarin) and apricot kernel oil. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (\>50%) between the estrogen group and the non-estrogen alternative group.

Interventions

  • DRUG Conjugated equine estrogen topical cream
  • DRUG Apricot kernel oil

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2017-01
Est. Completion 2019-12-31
Phase Phase 4
University of Louisville

217 total trials

What the finished NCT02869165 record still lists

NCT02869165 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Conjugated equine estrogen topical cream is the first listed.

NCT02869165 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02869165 about?

NCT02869165 is a clinical study titled "Vaginal and Urinary Microbiome Trial". A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause.

What is the current status of trial NCT02869165?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2017-01. Estimated completion is 2019-12-31.

What interventions are being tested in trial NCT02869165?

The interventions under investigation include: Conjugated equine estrogen topical cream (DRUG), Apricot kernel oil (DRUG).

Who is sponsoring clinical trial NCT02869165?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02869165's enrollment target sits among peer trials

110 727th of 2000 higher than 1,264 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT02869165, the US trial registry maintained by the National Library of Medicine. NCT02869165 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.