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NCT03739983 · OUTCOME

Change in Vaginal pH

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention · Source last updated 2021-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
up to 12 weeks

What was measured

Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014).

Analysis population: No data to analyze.

Groups in this outcome

VRP Therapy

All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
VRP Therapy0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014).
groups
  1. description
    All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
    id
    OG000
    title
    VRP Therapy
population Description
No data to analyze.
reporting Status
POSTED
time Frame
up to 12 weeks
title
Change in Vaginal pH
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice