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

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Treatments: Tadalafil

Criteria

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