"As Required" Oral Sildenafil in Raynaud's Phenomenon

Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)

The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.

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