Clinical Trial Results:
Effects of single dose tadalafil on urethral and anal closure function and on urinary flow in healthy females: A randomised, controlled, double-blinded, two-period cross-over study
Summary
|
|
EudraCT number |
2020-005839-76 |
Trial protocol |
DK |
Global end of trial date |
10 Jan 2022
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
27 Jul 2022
|
First version publication date |
27 Jul 2022
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
PDE5I-UPR-AAR-01
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05095077 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
University hospital Bispebjerg and Fred
|
||
Sponsor organisation address |
Bispebjerg Bakke 23, indgang 20C, 2., Copenhagen, Denmark, 2400
|
||
Public contact |
Information, Zelo phase 1 unit, +45 60770308, thea.christoffersen@regionh.dk
|
||
Scientific contact |
Information, Zelo phase 1 unit, +45 60770308, thea.christoffersen@regionh.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
01 Apr 2022
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
10 Jan 2022
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
10 Jan 2022
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
This study investigated the effect of tadalafil, a phosphodiesterase-type 5 (PDE-5) inhibitor, on urethral pressure, anal pressure and on urinary flow in healthy females.
|
||
Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. Written informed consent was obtained before any study related procedures. We performed minimally invasive measurements and used sterile technique where applicable.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Aug 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 24
|
||
Worldwide total number of subjects |
24
|
||
EEA total number of subjects |
24
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
24
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||
Recruitment
|
||||||||||
Recruitment details |
Healthy females were recruited by advertisement at the online research platform www.forsoegsperson.dk and via database with previous participants in similar trials. | |||||||||
Pre-assignment
|
||||||||||
Screening details |
Check of the in- and exclusion criteria, physical examination, vital signs | |||||||||
Period 1
|
||||||||||
Period 1 title |
Overall trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Assessor | |||||||||
Blinding implementation details |
Tadalafil and placebo were over-encapsultated in identical gelatine capsules
|
|||||||||
Arms
|
||||||||||
Are arms mutually exclusive |
No
|
|||||||||
Arm title
|
Tadalafil | |||||||||
Arm description |
Single oral dose of 40 mg tadalafil | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tadalafil
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Capsule, soft + tablet
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
40 mg once
|
|||||||||
Arm title
|
Placebo | |||||||||
Arm description |
Single oral dose placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Capsule, soft + tablet
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
major ingredients: Lactose monohydrate, Potato starch, Gelatine, Magnesium stearate, Talc, Gelatine capsule DB
|
|||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Tadalafil
|
||
Reporting group description |
Single oral dose of 40 mg tadalafil | ||
Reporting group title |
Placebo
|
||
Reporting group description |
Single oral dose placebo |
|
|||||||||||||
End point title |
Difference in mean resting opening urethral pressure (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
Tadalafil v Placebo
|
||||||||||||
Number of subjects included in analysis |
48
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-6.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-11.8 | ||||||||||||
upper limit |
-1.9 | ||||||||||||
Notes [1] - Crossover analysis |
|
|||||||||||||
End point title |
Difference in mean squeezing opening urethral pressure (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in mean resting anal opening pressure (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in mean squeezing anal opening pressure (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Assessment 2 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in average uroflow (Qave) (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Assessment 2.5 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in maximum uroflow (Qmax) (tadalafil vs placebo) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Assessment 2.5 hours after administration of study medication on both placebo day and tadalafil day
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From dosing on Study Day 1 to six days after Study Day 2
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
none | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Tadalafil
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |