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NCT01697345 · OUTCOME

FSFI Orgasm 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 orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.

Groups in this outcome

FSFI Orgasm Domain Score (Pretest)

Administered to participants prior to starting vaginal testosterone therapy.

FSFI Orgasm 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 Orgasm Domain Score (Pretest)12
FSFI Orgasm Domain Score (Posttest)12

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FSFI Orgasm Domain Score (Pretest)1.7331.767Not reportedNot reportedNot reported
FSFI Orgasm Domain Score (Posttest)2.9332.049Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -1.95080
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -.44920
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.18168
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.005
    param Type
    Mean Difference (Final Values)
    param Value
    -1.20000
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -1.95080
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -.44920
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.18168
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.005
    param Type
    Mean Difference (Final Values)
    param Value
    -1.20000
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.767
        value
        1.733
      2. group Id
        OG001
        spread
        2.049
        value
        2.933
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    units
    Participants
description
The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (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 Orgasm 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 Orgasm Domain Score (Posttest)
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline, 4 weeks
title
FSFI Orgasm Domain
type
PRIMARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice