Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers (INFLUX-VS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710099
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : October 6, 2011
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Condition or disease Intervention/treatment
Healthy Drug: sildenafil Drug: nitroprussiate iontophoresis

Detailed Description:
The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers
Study Start Date : July 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: sildenafil
systemic absorption of sildenafil
Active Comparator: 2
SNP iontophoresis
Drug: nitroprussiate iontophoresis
nitroprussiate iontophoresis

Primary Outcome Measures :
  1. variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil [ Time Frame: one hour ]

Secondary Outcome Measures :
  1. To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger [ Time Frame: one hour ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age over 18
  • No significant medical history

Exclusion Criteria:

  • Age under 18
  • Period of exclusion for an other study
  • Pregnancy
  • Breast feeding
  • Severe disease
  • Cigarette smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710099

Clinical Researsh Centre
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-Luc CRACOWSKI, MD Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: University Hospital, Grenoble Identifier: NCT00710099     History of Changes
Other Study ID Numbers: DCIC/08/08
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by University Hospital, Grenoble:
cutaneous microcirculation
Healthy volunteers

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents