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The design and methodology of premature ejaculation interventional studies

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and...

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Autor principal: McMahon, Chris G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002005/
https://www.ncbi.nlm.nih.gov/pubmed/27652224
http://dx.doi.org/10.21037/tau.2016.03.28
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author McMahon, Chris G.
author_facet McMahon, Chris G.
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description Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials.
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spelling pubmed-50020052016-09-20 The design and methodology of premature ejaculation interventional studies McMahon, Chris G. Transl Androl Urol Review Article Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. AME Publishing Company 2016-08 /pmc/articles/PMC5002005/ /pubmed/27652224 http://dx.doi.org/10.21037/tau.2016.03.28 Text en 2016 Translational Andrology and Urology. All rights reserved.
spellingShingle Review Article
McMahon, Chris G.
The design and methodology of premature ejaculation interventional studies
title The design and methodology of premature ejaculation interventional studies
title_full The design and methodology of premature ejaculation interventional studies
title_fullStr The design and methodology of premature ejaculation interventional studies
title_full_unstemmed The design and methodology of premature ejaculation interventional studies
title_short The design and methodology of premature ejaculation interventional studies
title_sort design and methodology of premature ejaculation interventional studies
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002005/
https://www.ncbi.nlm.nih.gov/pubmed/27652224
http://dx.doi.org/10.21037/tau.2016.03.28
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