Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis

Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma

Inclusion Criteria:

• Female with diagnosis of scleroderma
• Stable sexual relationship with male partner or be sexually active
• Raynaud phenomenon at least 6 times per week
• Willing to attempt sexual activity 1/month during study period

Exclusion Criteria:

• Severe internal organ problems related to scleroderma
• Other gynecologic problems
• Serious depression
• Receiving other experimental and Raynaud treatments