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NCT00984399 · OUTCOME

To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen · Source last updated 2025-12-09

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
Full Range
Time frame
Baseline

What was measured

The FSFI measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction and pain. An increase in FSFI score means better sexual function. The individual domain scores and full scale score of the FSFI are derived by the computational formula outlined in the table below. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the domain factor (see below). The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Domain Questions Score range Factor Minimum score Maximum score Desire 1, 2 1-5 0.6 1.2 6.0 Arousal 3, 4, 5, 6 0-5 0.3 0 6.0 Lubrication 7, 8, 9, 10 0-5 0.3 0 6.0 Orgasm 11, 12, 13 0-5 0.4 0 6.0 Satisfaction 14, 15, 16 0 (or 1)-5 0.4 0 6.0 Pain 17, 18, 19 0-5 0.4 0 6.0 Full Scale Score Range 2.0 36.0

Groups in this outcome

Letrozole

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.

Anastrozole

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.

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

Analysis denominator · Participants

GroupSource count
Letrozole12
Anastrozole19

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Letrozole14.61Not reported2.726.2Not reported
Anastrozole16.01Not reported5.225.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        26.2
        value
        14.61
      2. group Id
        OG001
        lower Limit
        5.2
        upper Limit
        25.9
        value
        16.01
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      19
    units
    Participants
description
The FSFI measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction and pain. An increase in FSFI score means better sexual function. The individual domain scores and full scale score of the FSFI are derived by the computational formula outlined in the table below. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the domain factor (see below). The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Domain Questions Score range Factor Minimum score Maximum score Desire 1, 2 1-5 0.6 1.2 6.0 Arousal 3, 4, 5, 6 0-5 0.3 0 6.0 Lubrication 7, 8, 9, 10 0-5 0.3 0 6.0 Orgasm 11, 12, 13 0-5 0.4 0 6.0 Satisfaction 14, 15, 16 0 (or 1)-5 0.4 0 6.0 Pain 17, 18, 19 0-5 0.4 0 6.0 Full Scale Score Range 2.0 36.0
dispersion Type
Full Range
groups
  1. description
    This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
    id
    OG000
    title
    Letrozole
  2. description
    This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
    id
    OG001
    title
    Anastrozole
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline
title
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice