Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

NCT ID: NCT05095077

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-01-01

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.

Conditions

Urinary Incontinence,Stress; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tadalafil

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.

Group Type: EXPERIMENTAL

Tadalafil 40 MG

Intervention Type: DRUG

Single dose on study day 1/2

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical to active IMP

Interventions

Tadalafil 40 MG

Single dose on study day 1/2

Intervention Type: DRUG

Placebo

Identical to active IMP

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Thea Christoffersen

Medical Doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thea Christoffersen

Role: PRINCIPAL_INVESTIGATOR

Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg

Locations

Zelo Phase 1 unit

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2020-005839-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PDE5I-UPR-AAR-01

Identifier Type: -

Identifier Source: org_study_id