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A randomized, double-blind, crossover, placebo-controlled comparative clinical trial of arginine aspartate plus adenosine monophosphate for the intermittent treatment of male erectile dysfunction.

Abstract

Efficacy and safety of l-arginine aspartate 8 g combined with 200 mg of adenosine monophosphate (AA) with placebo (PL) alone for intermittent treatment of mild-to-moderate erectile dysfunction (ED) were compared. The study design was a double-blind, PL-controlled, two-way crossover randomized clinical trial with 26 patients. Efficacy was assessed by International Index of Erectile Function (IIEF) and two additional validated questionnaires [the Erection Hardness Score (EHS) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). During each crossover period, separated by a 2-week wash-out period, drugs were administered orally, 1-2 h before sexual intercourse. Primary endpoint was a change in the IIEF. Secondary endpoints were patient and investigator assessments of treatment success. Investigators' and patients' assessment of efficacy was significantly improved by the combination vs. PL (p = 0.01 and p = 0.04 respectively]. EHS and EDITS questionnaires were both improved by the combination (p = 0.015 and p = 0.017 respectively). There was no significant difference in terms of tolerance between AA and PL or severe adverse events. ED patients demonstrated significant improvements in all IIEF domains with the exception of the Sexual Desire and Orgasmic Domains when treated with AA compared with PL. This pilot phase II study showed that the on-demand oral administration at a high dosage of l-arginine aspartate-adenosine monophosphate combination may be effective in patients with mild-to-moderate ED, is very well tolerated and could be tested as a safe first-line therapy in a larger size phase III study.

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  • Authors+Show Affiliations

    ,

    Department of Urology, Hôpital Foch, Suresnes, France.

    , , ,

    Source

    Andrology 1:2 2013 Mar pg 223-8

    MeSH

    Adenosine Monophosphate
    Administration, Oral
    Adult
    Aged
    Arginine
    Aspartic Acid
    Coitus
    Cross-Over Studies
    Double-Blind Method
    Erectile Dysfunction
    Humans
    Libido
    Male
    Middle Aged
    Patient Satisfaction
    Placebos
    Sexual Behavior
    Surveys and Questionnaires
    Treatment Outcome

    Pub Type(s)

    Clinical Trial, Phase II
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    23413135

    Citation

    Neuzillet, Y, et al. "A Randomized, Double-blind, Crossover, Placebo-controlled Comparative Clinical Trial of Arginine Aspartate Plus Adenosine Monophosphate for the Intermittent Treatment of Male Erectile Dysfunction." Andrology, vol. 1, no. 2, 2013, pp. 223-8.
    Neuzillet Y, Hupertan V, Cour F, et al. A randomized, double-blind, crossover, placebo-controlled comparative clinical trial of arginine aspartate plus adenosine monophosphate for the intermittent treatment of male erectile dysfunction. Andrology. 2013;1(2):223-8.
    Neuzillet, Y., Hupertan, V., Cour, F., Botto, H., & Lebret, T. (2013). A randomized, double-blind, crossover, placebo-controlled comparative clinical trial of arginine aspartate plus adenosine monophosphate for the intermittent treatment of male erectile dysfunction. Andrology, 1(2), pp. 223-8. doi:10.1111/j.2047-2927.2012.00046.x.
    Neuzillet Y, et al. A Randomized, Double-blind, Crossover, Placebo-controlled Comparative Clinical Trial of Arginine Aspartate Plus Adenosine Monophosphate for the Intermittent Treatment of Male Erectile Dysfunction. Andrology. 2013;1(2):223-8. PubMed PMID: 23413135.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized, double-blind, crossover, placebo-controlled comparative clinical trial of arginine aspartate plus adenosine monophosphate for the intermittent treatment of male erectile dysfunction. AU - Neuzillet,Y, AU - Hupertan,V, AU - Cour,F, AU - Botto,H, AU - Lebret,T, Y1 - 2012/12/26/ PY - 2012/07/30/received PY - 2012/10/30/revised PY - 2012/11/02/accepted PY - 2013/2/16/entrez PY - 2013/2/16/pubmed PY - 2013/7/31/medline SP - 223 EP - 8 JF - Andrology JO - Andrology VL - 1 IS - 2 N2 - Efficacy and safety of l-arginine aspartate 8 g combined with 200 mg of adenosine monophosphate (AA) with placebo (PL) alone for intermittent treatment of mild-to-moderate erectile dysfunction (ED) were compared. The study design was a double-blind, PL-controlled, two-way crossover randomized clinical trial with 26 patients. Efficacy was assessed by International Index of Erectile Function (IIEF) and two additional validated questionnaires [the Erection Hardness Score (EHS) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). During each crossover period, separated by a 2-week wash-out period, drugs were administered orally, 1-2 h before sexual intercourse. Primary endpoint was a change in the IIEF. Secondary endpoints were patient and investigator assessments of treatment success. Investigators' and patients' assessment of efficacy was significantly improved by the combination vs. PL (p = 0.01 and p = 0.04 respectively]. EHS and EDITS questionnaires were both improved by the combination (p = 0.015 and p = 0.017 respectively). There was no significant difference in terms of tolerance between AA and PL or severe adverse events. ED patients demonstrated significant improvements in all IIEF domains with the exception of the Sexual Desire and Orgasmic Domains when treated with AA compared with PL. This pilot phase II study showed that the on-demand oral administration at a high dosage of l-arginine aspartate-adenosine monophosphate combination may be effective in patients with mild-to-moderate ED, is very well tolerated and could be tested as a safe first-line therapy in a larger size phase III study. SN - 2047-2927 UR - https://www.unboundmedicine.com/medline/citation/23413135/full_citation L2 - https://doi.org/10.1111/j.2047-2927.2012.00046.x DB - PRIME DP - Unbound Medicine ER -