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NCT03180294 · OUTCOME

Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks

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

Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).

Analysis population: Eligible with 9 week 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 mg57
Bupropion 300 mg52
Placebo56

Reported measurements

Severity of dry mouth at its worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg56
Bupropion 300 mg52
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of decreased appetite at its worst= very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg52
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Interference of decreased appetite with usual or daily activities = very much

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg56
Bupropion 300 mg51
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Frequency of nausea = almost constantly

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg51
Placebo54
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg1Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of nausea at its worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg56
Bupropion 300 mg50
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of constipation at its worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg52
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of dizziness at its worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg52
Placebo54
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Interference of dizziness with usual or daily activities = very much

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg55
Bupropion 300 mg51
Placebo55
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Frequency of headache = almost constantly

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg52
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of headache at its worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg56
Bupropion 300 mg51
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Interference of headache with usual or daily activities = very much

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg56
Bupropion 300 mg51
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Severity of insomnia at it's worst = very severe

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg52
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
Interference of insomnia with usual or daily activities = very much

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg57
Bupropion 300 mg51
Placebo56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bupropion 150 mg0Not reportedNot reportedNot reportedNot reported
Bupropion 300 mg0Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of dry mouth at its worst = very severe
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of decreased appetite at its worst= very severe
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Interference of decreased appetite with usual or daily activities = very much
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        54
      units
      Participants
    title
    Frequency of nausea = almost constantly
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of nausea at its worst = very severe
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of constipation at its worst = very severe
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        54
      units
      Participants
    title
    Severity of dizziness at its worst = very severe
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        55
      units
      Participants
    title
    Interference of dizziness with usual or daily activities = very much
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Frequency of headache = almost constantly
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of headache at its worst = very severe
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Interference of headache with usual or daily activities = very much
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Severity of insomnia at it's worst = very severe
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      52
    3. group Id
      OG002
      value
      56
    units
    Participants
description
Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).
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 9 week data
reporting Status
POSTED
time Frame
9 weeks from start of study treatment (within 21 days of randomization).
title
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice