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Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

Primary Purpose

Urinary Incontinence,Stress, Fecal Incontinence

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Tadalafil 40 MG

Placebo

About this trial

This is an interventional treatment trial for Urinary Incontinence,Stress

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

Zelo Phase 1 unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tadalafil

Placebo

Arm Description

Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.

Outcomes

Primary Outcome Measures

Placebo-corrected change in opening urethral pressure after single dose tadalafil

Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).

Secondary Outcome Measures

Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).

Difference in average UOP-tadalafil and average UOP-placebo during squeezing.

Difference in average AOP-tadalafil and average AOP-placebo during squeezing.

Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).

Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively.

Full Information

NCT ID

NCT05095077

First Posted

August 26, 2021

Last Updated

April 4, 2022

Sponsor

University Hospital Bispebjerg and Frederiksberg

1. Study Identification

Unique Protocol Identification Number

NCT05095077

Brief Title

Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Bispebjerg and Frederiksberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence,Stress, Fecal Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

Two-period (AB/BA) crossover study

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The tadalafil tablets and placebo are over-encapsulated in identical hard-gelatin capsules. The over-encapsulation, packaging and labelling is performed by the hospital pharmacy.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tadalafil

Arm Type

Experimental

Arm Description

Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.

Intervention Type

Drug

Intervention Name(s)

Tadalafil 40 MG

Intervention Description

Single dose on study day 1/2

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Identical to active IMP

Primary Outcome Measure Information:

Title

Placebo-corrected change in opening urethral pressure after single dose tadalafil

Description

Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).

Time Frame

2 hours post-dose

Secondary Outcome Measure Information:

Title

Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).

Description

Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).

Time Frame

2-hours post-dose

Title

Difference in average UOP-tadalafil and average UOP-placebo during squeezing.

Time Frame

2-hours post-dose

Title

Difference in average AOP-tadalafil and average AOP-placebo during squeezing.

Time Frame

2-hours post-dose

Title

Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).

Time Frame

2-hours post-dose

Title

Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively.

Time Frame

2-hours post-dose

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thea Christoffersen

Organizational Affiliation

Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zelo Phase 1 unit

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

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