NCT05095077

Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.

Conditions

• Urinary Incontinence,Stress
• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Tadalafil 40 MG	Single dose on study day 1/2
DRUG	Placebo	Identical to active IMP

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-12-30
• Completion: 2022-01-01
• First posted: 2021-10-27
• Last updated: 2022-04-06

Locations

1 site across 1 country: Denmark