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NCT04493333 · OUTCOME

Difference in Vaginal pH From Baseline to Week 12

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors · Source last updated 2024-11-27

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

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
12 weeks (±1 week)

What was measured

Vaginal pH was used as an objective physiologic marker to determine the improvement in vaginal atrophy. pH is a measure of acidity and alkalinity and can range from 0 to 14, with 7 being neutral. Lower pH scores are acidic and higher pH scores are basic or alkaline. A normal healthy vaginal pH is 4.5. As the vaginal epithelium becomes thinner and more atrophic, the mucosa has less glycogen content and less lactobacilli to convert the glycogen into lactic acid, which results in an increase in the vaginal pH.

Analysis population: Out of 8 participants assigned to a treatment arm, only 2 had vaginal pH measured at both the baseline and 12-week visits.

Groups in this outcome

Intrarosa & Standard of Care Aromatase Inhibitor

Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).

Replens & Standard of Care Aromatase Inhibitor

Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).

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

Analysis denominator · Participants

GroupSource count
Intrarosa & Standard of Care Aromatase Inhibitor2
Replens & Standard of Care Aromatase Inhibitor0

Reported measurements

Source class 1
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Intrarosa & Standard of Care Aromatase Inhibitor-1.002.83Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.83
        value
        -1.00
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Vaginal pH was used as an objective physiologic marker to determine the improvement in vaginal atrophy. pH is a measure of acidity and alkalinity and can range from 0 to 14, with 7 being neutral. Lower pH scores are acidic and higher pH scores are basic or alkaline. A normal healthy vaginal pH is 4.5. As the vaginal epithelium becomes thinner and more atrophic, the mucosa has less glycogen content and less lactobacilli to convert the glycogen into lactic acid, which results in an increase in the vaginal pH.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
    id
    OG000
    title
    Intrarosa & Standard of Care Aromatase Inhibitor
  2. description
    Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
    id
    OG001
    title
    Replens & Standard of Care Aromatase Inhibitor
param Type
MEAN
population Description
Out of 8 participants assigned to a treatment arm, only 2 had vaginal pH measured at both the baseline and 12-week visits.
reporting Status
POSTED
time Frame
12 weeks (±1 week)
title
Difference in Vaginal pH From Baseline to Week 12
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice