NCT03180294 · OUTCOME

Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")

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: MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

What was measured

The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

Analysis population: Eligible participants with baseline and 9 week data

Groups in this outcome

Bupropion 150 mg

One Bupropion 150 mg XL capsule by mouth (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

Group	Source count
Bupropion 150 mg	66
Bupropion 300 mg	59
Placebo	63

Reported measurements

Source class 1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bupropion 150 mg	0.64	0.95	Not reported	Not reported	Not reported
Bupropion 300 mg	0.60	0.89	Not reported	Not reported	Not reported
Placebo	0.62	1.18	Not reported	Not reported	Not reported

Source statistical analyses

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

group Description
Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.46
statistical Method
t-test, 1 sided
group Description
Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.54
statistical Method
t-test, 1 sided

Complete source fields

analyses

group Description
Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.46
statistical Method
t-test, 1 sided
group Description
Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.54
statistical Method
t-test, 1 sided

classes

categories
measurements
group Id
OG000
spread
0.95
value
0.64
group Id
OG001
spread
0.89
value
0.60
group Id
OG002
spread
1.18
value
0.62

denoms

counts
group Id
OG000
value
66
group Id
OG001
value
59
group Id
OG002
value
63
units
Participants

description

dispersion Type

Standard Deviation

groups

description
One Bupropion 150 mg XL capsule by mouth (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
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
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

MEAN

population Description

Eligible participants with baseline and 9 week data

reporting Status

POSTED

time Frame

Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

title

Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")

type

PRIMARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice