NCT00931528 · OUTCOME

Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy · Source last updated 2018-02-14

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

Measure: MEAN
Unit: change in SAQ score
Interval / dispersion: Standard Deviation
Time frame: Baseline, week 30 and years 1 and 2 after the start of treatment

What was measured

The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

Analysis population: Consenting partners of randomized eligible patients with data at baseline and corresponding time point

Groups in this outcome

Tadalafil

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.

Placebo

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

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
Tadalafil	42
Placebo	40

Reported measurements

Week 30

Analysis denominator · Participants

Group	Source count
Tadalafil	27
Placebo	20

Values in change in SAQ score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tadalafil	-4.9	7.5	Not reported	Not reported	Not reported
Placebo	-1.8	8.2	Not reported	Not reported	Not reported

Year 1

Analysis denominator · Participants

Group	Source count
Tadalafil	21
Placebo	20

Values in change in SAQ score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tadalafil	-3.9	6.4	Not reported	Not reported	Not reported
Placebo	-2.5	7.1	Not reported	Not reported	Not reported

Year 2

Analysis denominator · Participants

Group	Source count
Tadalafil	18
Placebo	16

Values in change in SAQ score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tadalafil	1.5	5.5	Not reported	Not reported	Not reported
Placebo	5.1	9.6	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
Week 30
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.14
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided
group Description
Year 1
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.64
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided
group Description
Year 2
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.18
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided

Complete source fields

analyses

group Description
Week 30
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.14
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided
group Description
Year 1
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.64
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided
group Description
Year 2
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.18
statistical Comment
Significance level = 0.05
statistical Method
t-test, 2 sided

classes

categories
measurements
group Id
OG000
spread
7.5
value
-4.9
group Id
OG001
spread
8.2
value
-1.8
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
20
units
Participants
title
Week 30
categories
measurements
group Id
OG000
spread
6.4
value
-3.9
group Id
OG001
spread
7.1
value
-2.5
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
20
units
Participants
title
Year 1
categories
measurements
group Id
OG000
spread
5.5
value
1.5
group Id
OG001
spread
9.6
value
5.1
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
16
units
Participants
title
Year 2

denoms

counts
group Id
OG000
value
42
group Id
OG001
value
40
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
id
OG000
title
Tadalafil
description
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
id
OG001
title
Placebo

param Type

MEAN

population Description

Consenting partners of randomized eligible patients with data at baseline and corresponding time point

reporting Status

POSTED

time Frame

Baseline, week 30 and years 1 and 2 after the start of treatment

title

Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score

type

SECONDARY

unit Of Measure

change in SAQ score

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice