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...
Brief Summary
Official 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”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: July 2002
Intervention(s) in this Clinical Trial
- Drug: Cialis
- 35 pills of study medication (20 mg)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
- Experimental: 2
- 35 placebo pills followed with 35 study medication (20 mg)
Outcome Measures for this Clinical Trial
Primary Measures
- Number of Raynaud attacks
- Time Frame: 16 weeks
Safety Issue?: No
- Time Frame: 16 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Medicine and Dentistry New Jersey Other
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00707187
Study ID Number: 0220013701
ClinicalTrials.gov Identifier: NCT00707187
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00707187
