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Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

NCT05095077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-06

No results posted yet for this study

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

DRUG

Tadalafil 40 MG

Single dose on study day 1/2

DRUG

Placebo

Identical to active IMP

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Principal Investigators

  • Thea Christoffersen · Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2021-12-30
Completion
2022-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095077 on ClinicalTrials.gov