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NCT01697345 · OUTCOME

FSFI Satisfaction Domain

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy · Source last updated 2014-01-24

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, 4 weeks

What was measured

The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.

Groups in this outcome

FSFI Satisfaction Domain Score (Pretest)

Administered to participants prior to starting vaginal testosterone therapy.

FSFI Satisfaction Domain Score (Posttest)

Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).

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

Analysis denominator · Participants

GroupSource count
FSFI Satisfaction Domain Score (Pretest)12
FSFI Satisfaction Domain Score (Posttest)12

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FSFI Satisfaction Domain Score (Pretest)2.3001.311Not reportedNot reportedNot reported
FSFI Satisfaction Domain Score (Posttest)4.2001.293Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -2.761
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.039
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.355
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -1.900
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -2.761
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.039
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.355
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -1.900
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.311
        value
        2.300
      2. group Id
        OG001
        spread
        1.293
        value
        4.200
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    units
    Participants
description
The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.
dispersion Type
Standard Deviation
groups
  1. description
    Administered to participants prior to starting vaginal testosterone therapy.
    id
    OG000
    title
    FSFI Satisfaction Domain Score (Pretest)
  2. description
    Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
    id
    OG001
    title
    FSFI Satisfaction Domain Score (Posttest)
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline, 4 weeks
title
FSFI Satisfaction Domain
type
PRIMARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice