Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study.
BACKGROUND
There is partial evidence to support the use of phophodiesterase-5 inhibitor (PDE5-I) for the treatment of premature ejaculation (PE).


OBJECTIVE
We compared on-demand dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction (ED).


METHODS
Our prospective, randomized, double-blind, placebo-controlled, multicenter trial enrolled 118 subjects with lifelong PE without ED. PE was diagnosed using Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Patients were divided into two groups: dapoxetine 30 mg plus placebo (group A, n=56) and dapoxetine 30 mg plus mirodenafil 50 mg (group B, n=62).


METHODS
During 12 weeks, intravaginal ejaculatory latency time (IELT) and the time from foreplay to beginning intercourse (FTIT) with a stopwatch, and Premature Ejaculation Profile (PEP) were measured. Overall sexual act time (OSAT; sum of FTIT and IELT) was calculated. Any treatment-emergent adverse events (TEAEs) were also recorded.


RESULTS
Over 12 weeks, IELT, OSAT, and PEP index score significantly improved in group B compared with group A (increased geometric mean IELT in group A and B=3.6 and 6.1 minutes, P=0.026; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes, P=0.012; increased median PEP index score in group A and B=1.0 and 1.3, P=0.046). However, there was no significant difference between two groups with respect to improvement of FTIT (P=0.147). TEAEs did not differ between groups (all P>0.05), and there was no serious adverse event in any subjects.


CONCLUSIONS
Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED.
Department of Urology, College of Medicine, Hallym Unversity, Chuncheon Sacred Heart Hospital, Chuncheon, Korea.
Won Ki
WK
Lee
Seong Ho
SH
Lee
Sung Tae
ST
Cho
Yong Sung
YS
Lee
Cheol Young
CY
Oh
Changhee
C
Yoo
Jin Seon
JS
Cho
Sang Kon
SK
Lee
Dae Yul
DY
Yang
D000328:Adult; D000368:Aged; D001596:Benzylamines / Q000008:administration & dosage*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D010919:Placebos; D061686:Premature Ejaculation / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome
D001596:Benzylamines; D009281:Naphthalenes; D058986:Phosphodiesterase 5 Inhibitors; D010919:Placebos; D011744:Pyrimidinones; D017367:Selective Serotonin Reuptake Inhibitors; D013449:Sulfonamides; C528396:mirodenafil; C080598:dapoxetine
Dapoxetine; Intravaginal Ejaculatory Latency Time; Mirodenafil; Premature Ejaculation