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

Phase 2

Completed

• Conditions: Systemic Sclerosis
• Interventions: Drug: Cialis

• Registration Number: NCT00707187
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Status Verified: 2008-06
• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-27
• Last Update Submitted: 2008-06-27
• Study First Posted: 2008-06-30
• Last Update Posted: 2008-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Cialis	35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
2	Cialis	35 placebo pills followed with 35 study medication (20 mg)

Primary Outcome Measures

Name	Time	Method
Number of Raynaud attacks	16 weeks

Trial Locations

Locations (1)

UMDNJ; 🇺🇸 New Brunswick, New Jersey, United States