TY - JOUR
T1 - Standards for clinical trials in male sexual dysfunctions
AU - Porst, Hartmut
AU - Vardi, Yoram
AU - Akkus, Emre
AU - Melman, Arnold
AU - Park, Nam Cheol
AU - Seftel, Allen D.
AU - Teloken, Claudio
AU - Wyllie, Michael
N1 - Funding Information:
These key features of PE are considered in two different validated PRO-based questionnaires. One of these questionnaires (IPE) was developed with the financial support of Pfizer USA [75] and the other (Premature Ejaculation Profile [PEP; Table 7 ]) with the financial support of Johnson & Johnson, USA and was used in the dapoxetine clinical research program [84] .
PY - 2010/1
Y1 - 2010/1
N2 - Introduction: Clinical trials in male sexual dysfunction (MSD) are expanding. Consequently, there is a need for consensus standards in this area. Aim: 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. Main Outcome Measure: 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.
AB - Introduction: Clinical trials in male sexual dysfunction (MSD) are expanding. Consequently, there is a need for consensus standards in this area. Aim: 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. Main Outcome Measure: 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.
KW - Clinical trials
KW - Ejaculatory disorders
KW - Erectile dysfunction
KW - Hypogonadism
KW - Male sexual dysfunction
KW - Peyronie's disease
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U2 - 10.1111/j.1743-6109.2009.01623.x
DO - 10.1111/j.1743-6109.2009.01623.x
M3 - Article
C2 - 20092447
AN - SCOPUS:74049146039
SN - 1743-6095
VL - 7
SP - 414
EP - 444
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 1 PART 2
ER -