Trial record 1 of 7 for:    Scleroderma AND (woman OR women OR female)
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Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey Identifier:
First received: June 25, 2008
Last updated: June 27, 2008
Last verified: June 2008

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

Condition Intervention Phase
Systemic Sclerosis
Drug: Cialis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Number of Raynaud attacks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2001
Estimated Study Completion Date: July 2002
Estimated Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
Drug: Cialis
35 pills of study medication (20 mg)
Experimental: 2
35 placebo pills followed with 35 study medication (20 mg)
Drug: Cialis
35 pills of study medication (20 mg)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00707187

United States, New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: James R. Seibold, Professor and Director, UMDNJ Identifier: NCT00707187     History of Changes
Other Study ID Numbers: 0220013701
Study First Received: June 25, 2008
Last Updated: June 27, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
systemic sclerosis
raynaud phenomenon

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Sexual Dysfunctions, Psychological
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses processed this record on April 22, 2014