Urinary stress incontinence and fecal incontinence MedDRA version: 22.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Tadalafil Stada 20 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
University hospital Bispebjerg and Frederiksberg, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female between 18 and 55 years old (both included) • Signed informed consent form • Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2) • Use of safe contraceptive methods throughout the course of the study i.e. intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections) through the entire trial and until six days after the study has ended for the subject. Subjects who are postmenopausal (defined as no menses for 12 months or more prior enrolment) can be included without use of contraceptive products. • Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 140 mmHg and/or average diastolic blood pressure 90 mmHg (average of three measurements performed at screening) • Average pulse 100 beats/minute (average of three measurements performed at screening) • Pregnancy within 6 months before screening and throughout the study • Breastfeeding within 3 months before screening • Any 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) within 3 months before screening • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study investigates the effect of tadalafil, a phosphodiesterase-type 5 (PDE-5) inhibitor, on urethral pressure in healthy female volunteers.;Secondary Objective: To assess the effect of tadalafil on anal pressure, on uroflow parametres, and on the urethral - and anal blood pressure.;Primary end point(s): • Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).;Timepoint(s) of evaluation of this end point: Two hours post dose of study drug (tadalafil/placebo) on study day 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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). • Hysteresis during relaxation and squeezing (tadalafil compared to placebo). • Urethral and anal blood pressure profiles. • Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively. • Difference in voided volume after tadalafil and placebo administration, respectively. ;Timepoint(s) of evaluation of this end point: Two hours post dose of study drug (tadalafil/placebo) on study day 1 and 2. | — |
Countries
Denmark
Contacts
Public ContactInformation
Zelo phase 1 unit
Outcome results
None listed