Standards for clinical trials in male sexual dysfunctions

Hartmut Porst, Yoram Vardi, Emre Akkus, Arnold Melman, Nam Cheol Park, Allen D. Seftel, Claudio Teloken, Michael Wyllie

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)414-444
Number of pages31
JournalJournal of Sexual Medicine
Volume7
Issue number1 PART 2
DOIs
StatePublished - Jan 2010

Fingerprint

Clinical Trials
Premature Ejaculation
Penile Induration
Libido
Consensus
Ejaculation
Hypogonadism
Expert Testimony
Erectile Dysfunction
Peer Review
Manuscripts
Developed Countries
Publications
Reading
Referral and Consultation
Research Personnel
Medicine
Outcome Assessment (Health Care)

Keywords

  • Clinical trials
  • Ejaculatory disorders
  • Erectile dysfunction
  • Hypogonadism
  • Male sexual dysfunction
  • Peyronie's disease

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Porst, H., Vardi, Y., Akkus, E., Melman, A., Park, N. C., Seftel, A. D., ... Wyllie, M. (2010). Standards for clinical trials in male sexual dysfunctions. Journal of Sexual Medicine, 7(1 PART 2), 414-444. https://doi.org/10.1111/j.1743-6109.2009.01623.x

Standards for clinical trials in male sexual dysfunctions. / Porst, Hartmut; Vardi, Yoram; Akkus, Emre; Melman, Arnold; Park, Nam Cheol; Seftel, Allen D.; Teloken, Claudio; Wyllie, Michael.

In: Journal of Sexual Medicine, Vol. 7, No. 1 PART 2, 01.2010, p. 414-444.

Research output: Contribution to journalArticle

Porst, H, Vardi, Y, Akkus, E, Melman, A, Park, NC, Seftel, AD, Teloken, C & Wyllie, M 2010, 'Standards for clinical trials in male sexual dysfunctions', Journal of Sexual Medicine, vol. 7, no. 1 PART 2, pp. 414-444. https://doi.org/10.1111/j.1743-6109.2009.01623.x
Porst H, Vardi Y, Akkus E, Melman A, Park NC, Seftel AD et al. Standards for clinical trials in male sexual dysfunctions. Journal of Sexual Medicine. 2010 Jan;7(1 PART 2):414-444. https://doi.org/10.1111/j.1743-6109.2009.01623.x
Porst, Hartmut ; Vardi, Yoram ; Akkus, Emre ; Melman, Arnold ; Park, Nam Cheol ; Seftel, Allen D. ; Teloken, Claudio ; Wyllie, Michael. / Standards for clinical trials in male sexual dysfunctions. In: Journal of Sexual Medicine. 2010 ; Vol. 7, No. 1 PART 2. pp. 414-444.
@article{b1d8c4428e274afe99f2561315ece407,
title = "Standards for clinical trials in male sexual dysfunctions",
abstract = "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.",
keywords = "Clinical trials, Ejaculatory disorders, Erectile dysfunction, Hypogonadism, Male sexual dysfunction, Peyronie's disease",
author = "Hartmut Porst and Yoram Vardi and Emre Akkus and Arnold Melman and Park, {Nam Cheol} and Seftel, {Allen D.} and Claudio Teloken and Michael Wyllie",
year = "2010",
month = "1",
doi = "10.1111/j.1743-6109.2009.01623.x",
language = "English (US)",
volume = "7",
pages = "414--444",
journal = "Journal of Sexual Medicine",
issn = "1743-6095",
publisher = "Wiley-Blackwell",
number = "1 PART 2",

}

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

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

UR - http://www.scopus.com/inward/record.url?scp=74049146039&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=74049146039&partnerID=8YFLogxK

U2 - 10.1111/j.1743-6109.2009.01623.x

DO - 10.1111/j.1743-6109.2009.01623.x

M3 - Article

VL - 7

SP - 414

EP - 444

JO - Journal of Sexual Medicine

JF - Journal of Sexual Medicine

SN - 1743-6095

IS - 1 PART 2

ER -