Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Sclerosis
Intervention: Cialis (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Medicine and Dentistry of New Jersey
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Raynaud attacks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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 and Contacts
UMDNJ, New Brunswick, New Jersey 08903, United States
Additional Information
Starting date: July 2001
Last updated: June 27, 2008
|