NCT04493333 · OUTCOME

Difference in Vaginal Dryness Subscale Scores on the Female Sexual Dysfunction Index (FSFI) 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

The Vaginal Dryness (or Lubrication) Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so more lubrication.

Analysis population: Out of 8 participants assigned to a treatment arm, only 2 took the FSFI 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

Group	Source count
Intrarosa & Standard of Care Aromatase Inhibitor	2
Replens & Standard of Care Aromatase Inhibitor	0

Reported measurements

Source class 1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Intrarosa & Standard of Care Aromatase Inhibitor	1.80	2.55	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.55
value
1.80

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
0
units
Participants

description

The Vaginal Dryness (or Lubrication) Subscale Score on the Female Sexual Dysfunction Index ranges from 0-5 with higher scores indicating better sexual function, so more lubrication.

dispersion Type

Standard Deviation

groups

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
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 took the FSFI at both the baseline and 12-week visits.

reporting Status

POSTED

time Frame

12 weeks (±1 week)

title

Difference in Vaginal Dryness Subscale Scores on the Female Sexual Dysfunction Index (FSFI) 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