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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00707187
• Date of registration: 25/06/2008
• Prospective Registration: No
• Primary sponsor: University of Medicine and Dentistry of New Jersey
• Public title: Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
• Scientific title: 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
• Date of first enrolment: July 2001
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00707187
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Cialis

Primary Outcome(s)

Number of Raynaud attacks [Time Frame: 16 weeks]

Secondary ID(s)

0220013701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors