Standards for clinical trials in male sexual dysfunctions.
BACKGROUND
Clinical trials in male sexual dysfunction (MSD) are expanding. Consequently, there is a need for consensus standards in this area.


OBJECTIVE
To develop an evidence-based, state-of-the-art consensus report on standards for clinical trials in MSD.


METHODS
A literature review was performed examining clinical trials in erectile dysfunction (ED), premature ejaculation (PE), delayed/absent ejaculation, libido disorders/loss of desire, hypogonadism, and Peyronie's disease, focusing on publications published in the last 20 years. This manuscript represents the opinions of eight experts from seven countries developed in a consensus process. This document was presented for peer review and debate in a public forum and revisions were made based on recommendations of chairpersons to the International Consultation on Sexual Medicine.


METHODS
Expert opinion was based on the grading of evidence-based medical literature, widespread internal committee discussion, public presentation, and debate.


RESULTS
According to experience and recent publications in dealing with clinical trials in sexual dysfunction, recommendations have been made for conducting trials in patients with ED, PE, delayed ejaculation, libido disorders, hypogonadism, and Peyronie's disease.


CONCLUSIONS
It is important that future clinical trials are conducted using standards upon which investigators can rely when reading manuscripts or conducting new trials in this field.
Porst
Hartmut
H
Porst20354@aol.com
Vardi
Yoram
Y
Akkus
Emre
E
Melman
Arnold
A
Park
Nam Cheol
NC
Seftel
Allen D
AD
Teloken
Claudio
C
Wyllie
Michael
M
D002986:Clinical Trials as Topic; D004542:Ejaculation; D007172:Erectile Dysfunction / Q000453:epidemiology* / Q000628:therapy*; D006801:Humans; D007006:Hypogonadism / Q000453:epidemiology / Q000628:therapy; D007398:Interpersonal Relations; D008297:Male; D010411:Penile Induration / Q000453:epidemiology / Q000628:therapy; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use; D015995:Prevalence; D012735:Sexual Dysfunction, Physiological / Q000453:epidemiology* / Q000628:therapy*; D012747:Sexual Partners
D010726:Phosphodiesterase Inhibitors