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

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

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Key information

Conditions

Systemic Sclerosis Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UMDNJ

New Brunswick, New Jersey, 08903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cialis

Drug

35 pills of study medication (20 mg)

Primary outcomes

Number of Raynaud attacks

Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Registry information

Official study 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

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: Jun 30, 2008
Registry last updated: Jun 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed