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NCT04493333 · OUTCOME

Difference in Vaginal Maturation Index (VMI) Response 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
Baseline and 12 weeks (±1 week)

What was measured

The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \< 50 indicates atrophy.

Analysis population: Out of 8 participants assigned to a treatment arm, only 2 had VMI 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-7.524.75Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.75
        value
        -7.5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    units
    Participants
description
The change in the subject's calculated VMI from baseline to the end of treatment at 12 weeks (±1 week). VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is the same as VMI = %S + (0.5 x %I) when simplified. It has a potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \< 50 indicates atrophy.
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 VMI measured at both the baseline and 12-week visits.
reporting Status
POSTED
time Frame
Baseline and 12 weeks (±1 week)
title
Difference in Vaginal Maturation Index (VMI) Response From Baseline to Week 12
type
PRIMARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice