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

University of Medicine and Dentistry of New Jersey120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Systemic Sclerosis

Interventions

CialisDRUG

35 pills of study medication (20 mg)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UMDNJ

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Number of Raynaud attacks

Time frame: 16 weeks

Data from ClinicalTrials.gov

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