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

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: Cialis

Study type: Interventional

Funder types: Other

Identifiers

NCT00707187

0220013701

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 2 patient groups

1

Experimental group

Description:

35 doses of study medication, IC 351 (20 mg) -- crossover to placebo

Treatment:

Drug: Cialis

2

Experimental group

Description:

35 placebo pills followed with 35 study medication (20 mg)

Treatment:

Drug: Cialis