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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Single dose on study day 1/2
Identical to active IMP
Zelo Phase 1 unit
Copenhagen, Denmark
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).
Time frame: 2 hours post-dose
Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).
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
Difference in average UOP-tadalafil and average UOP-placebo during squeezing.
Time frame: 2-hours post-dose
Difference in average AOP-tadalafil and average AOP-placebo during squeezing.
Time frame: 2-hours post-dose
Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).
Time frame: 2-hours post-dose
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.