CompletedPhase 2

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

United States120 participantsStarted 2001-07

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Number of Raynaud attacks

Timeframe: 16 weeks

Trial details

NCT IDNCT00707187

SponsorUniversity of Medicine and Dentistry of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2002-07

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