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Effects of Single Dose Tadalafil on Urethral and Anal Closure Function | Clinical Trials | Clareo Health

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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

NCT05095077•University Hospital Bispebjerg and Frederiksberg

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Signed informed consent form
•Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
•Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.
•Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)

Exclusion Criteria

•History of clinically significant urinary incontinence.
•Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator.
•Average systolic blood pressure \<100 mmHg or \>140 mmHg and/or average diastolic blood pressure \<60 mmHg or \>90 mmHg (average of three measurements performed at screening).
•Average pulse \< 40 or \> 100 beats/minute (average of three measurements performed at screening).
•Pregnancy within 6 months before screening and throughout the study period.
•Breastfeeding throughout the study period and 6 days after study day 2.
•Any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy.
•Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months.
•Alcohol consume 24 hours prior to dosing.
•Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).

Locations (1)

Zelo Phase 1 unit

Copenhagen, Denmark

Key Dates

Start Date

August 1, 2021

Primary Completion Date

December 30, 2021

Completion Date

January 1, 2022

Last Updated

April 6, 2022

Enrollment

ACTUAL participants

Conditions

Urinary Incontinence,StressFecal Incontinence

Interventions

Tadalafil 40 MG

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

Inclusion Criteria

Exclusion Criteria

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