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"As Required" Oral Sildenafil in Raynaud's Phenomenon (PROFIL)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Grenoble Identifier:
First received: January 28, 2014
Last updated: January 15, 2016
Last verified: January 2016
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.

Condition Intervention Phase
Raynaud's Phenomenon
Drug: Sildenafil 40 mg
Drug: Sildenafil 80 mg
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)

Resource links provided by NLM:

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo. [ Time Frame: 7 days ]
    RCS is self-reported every day and averaged over 7-day periods

Secondary Outcome Measures:
  • Frequency of RP: number of RP attacks during treatment, as compared to placebo. [ Time Frame: 7 days ]
    An attack is defined as an episode of pallor or cyanosis (with or without pain,tingling or numbness). The number of attacks is self-reported every day and averaged over 7-day periods

  • Patients' preference: comparison between the number of patients favoring a treatment to another. [ Time Frame: Every 3 weeks of treatment (week 3, 6 and 9) ]
  • Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo. [ Time Frame: 7 days ]
    Pain associated with each attack is self-reported on a 10-point scale, and averaged over 7-day periods

  • Frequency and severity of adverse drug events during treatment, as compared to placebo [ Time Frame: 7 days ]
  • Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments) [ Time Frame: Week 1, 2 and 3 ]

Enrollment: 41
Study Start Date: November 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil 80 mg
Sildenafil 80 mg
Drug: Sildenafil 80 mg
Experimental: Sildenafil 40 mg
Sildenafil 40 mg
Drug: Sildenafil 40 mg
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
  • At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
  • Patients who have dated and signed the informed consent form
  • Contraception for women

Exclusion Criteria:

  • Recently diagnosed RP (less than 2 months).
  • Uncontrolled hypertension, diabetes mellitus, angina
  • Haemodynamic instability
  • Nonarteritic ischemic optic neuropathy
  • Pulmonary hypertension
  • Subjects currently taking sildenafil, tadalafil or vardenafil
  • Subjects currently taking nitrates
  • Subjects currently taking strong CYP3A inhibitors
  • Pregnancy (or considering pregnancy in the next 4 months)
  • Breast feeding
  • Participation in another clinical trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT02050360

Clinical Investigation Center - Pharmacology Unit - University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-Luc CRACOWSKI, MD INSERM CIC03 - Unité de Pharmacologie Clinique
  More Information

Responsible Party: University Hospital, Grenoble Identifier: NCT02050360     History of Changes
Other Study ID Numbers: DCIC/12/26
2013-000014-38 ( EudraCT Number )
12G01 ( Other Identifier: Promotor )
Study First Received: January 28, 2014
Last Updated: January 15, 2016

Keywords provided by University Hospital, Grenoble:
Raynaud's phenomenon
Systemic Sclerosis
Local cooling

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on May 25, 2017