Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study.
BACKGROUND
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at-home setting has not been evaluated.


OBJECTIVE
The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg.


METHODS
The multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase-2 study enrolled men at least 21 years old with a minimum 3-month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8-10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse.


METHODS
The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one-minute intervals using a step-down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method.


RESULTS
Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing (P = 0.012). Response to tadalafil 10 mg approached significance (P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg (P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg (P = 0.042). Fifty-two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo (P = 0.038).


CONCLUSIONS
This stopwatch-based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg.
Rosen
Raymond C
RC
Robert Wood Johnson Medical School, Piscataway, NJ, USA. rosen@umdnj.edu
Padma-Nathan
Harin
H
Shabsigh
Ridwan
R
Saikali
Khalil
K
Watkins
Vish
V
Pullman
William
W
D000328:Adult; D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D003075:Coitus / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012725:Sexual Behavior / Q000187:drug effects*; D000068581:Tadalafil; D013997:Time Factors; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D000068581:Tadalafil