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NCT03180294 · OUTCOME

Global Impression of Change at 9 Weeks ("Perception of Change")

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer · Source last updated 2026-07-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
9 weeks from start of study treatment (within 21 days of randomization)

What was measured

Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol.

Analysis population: Eligible with data

Groups in this outcome

Bupropion 150 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).

Bupropion 300 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)

Placebo

One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)

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

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg66
Bupropion 300 mg60
Placebo63

Reported measurements

Source class 1

Not Better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg43Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg36Not reportedNot reportedNot reportedNot reported
Placebo43Not reportedNot reportedNot reportedNot reported

Better

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg23Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg24Not reportedNot reportedNot reportedNot reported
Placebo20Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.71
    statistical Comment
    One-sided significance level 0.05
    statistical Method
    Chi-squared
  2. group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.34
    statistical Comment
    One-sided significance level 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.71
    statistical Comment
    One-sided significance level 0.05
    statistical Method
    Chi-squared
  2. group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.34
    statistical Comment
    One-sided significance level 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        43
      title
      Not Better
    2. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        20
      title
      Better
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      63
    units
    Participants
description
Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol.
groups
  1. description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    id
    OG000
    title
    Bupropion 150 mg
  2. description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    id
    OG001
    title
    Bupropion 300 mg
  3. description
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    id
    OG002
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible with data
reporting Status
POSTED
time Frame
9 weeks from start of study treatment (within 21 days of randomization)
title
Global Impression of Change at 9 Weeks ("Perception of Change")
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice