Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects ... View Full Text


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Article Info

DATE

2004-04

AUTHORS

R C Rosen, L E Diamond, D C Earle, A M Shadiack, P B Molinoff

ABSTRACT

PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following subcutaneous administration to healthy male subjects and to patients with erectile dysfunction (ED) who report an inadequate response to Viagra. An inadequate response was defined for this study by patient report indicating that achievement of an erection suitable for vaginal penetration occurred < or =50% of the time while taking 100 mg Viagra. Erectile responses were assessed by RigiScan in healthy subjects in the absence of visual sexual stimulation (VSS) and in ED patients in the presence of VSS. Doses ranging from 0.3 to 10 mg were administered to healthy male subjects, resulting in a statistically significant erectile response at doses greater than 1.0 mg. ED patients were treated with placebo, 4 or 6 mg PT-141 in a crossover design in the presence of VSS. The erectile response induced by PT-141 was statistically significant at both doses. PT-141 was safe and well tolerated in both studies. The erectogenic potential of PT-141, its tolerability profile and its ability to cause significant erections in patients who do not have an adequate response to a PDE5 inhibitor suggest that PT-141 may provide an alternative treatment for ED with a potentially broad patient base. More... »

PAGES

3901200

References to SciGraph publications

  • 2001-08. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2000-10. The worldwide prevalence and epidemiology of erectile dysfunction in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
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  • 2001-02. On-demand IC351 (Cialis™) enhances erectile function in patients with erectile dysfunction in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2002-02. New directions for erectile dysfunction therapies in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2002-08. Incidence and determinants of sildenafil (dis)continuation: the Dutch cohort of sildenafil users in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2002-09. Clinical Posters 4: Female Sexual Function and DysfunctionWednesday, September 25 in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2002-02. Sildenafil citrate: lessons learned from 3 years of clinical experience in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • 2004-01. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction in INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/sj.ijir.3901200

    DOI

    http://dx.doi.org/10.1038/sj.ijir.3901200

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1033032667

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/14999221


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