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...
Date First Received: June 25, 2008
Last Updated: June 27, 2008
Verified by: University of Medicine and Dentistry New Jersey, June 2008
Clinical Trial Phase: Phase 2 | Start Date: July 2001
Overall Status: Completed
Estimated Enrollment: 120
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: University of Medicine and Dentistry New Jersey
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
