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

This study has been completed.
Sponsor:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00707187
First received: June 25, 2008
Last updated: June 27, 2008
Last verified: June 2008
History of Changes
  Purpose

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:

MedlinePlus related topics: Scleroderma
Drug Information available for: Tadalafil
U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707187

Locations
United States, New Jersey
UMDNJ
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
ClinicalTrials.gov 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 University of Medicine and Dentistry New Jersey:
systemic sclerosis
scleroderma
raynaud phenomenon

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

ClinicalTrials.gov processed this record on June 18, 2013