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

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ClinicalTrials.gov Identifier: NCT00707187
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : June 30, 2008
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey

June 25, 2008
June 30, 2008
June 30, 2008
July 2001
July 2002   (Final data collection date for primary outcome measure)
Number of Raynaud attacks [ Time Frame: 16 weeks ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Systemic Sclerosis
Drug: Cialis
35 pills of study medication (20 mg)
  • Experimental: 1
    35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
    Intervention: Drug: Cialis
  • Experimental: 2
    35 placebo pills followed with 35 study medication (20 mg)
    Intervention: Drug: Cialis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
July 2002
July 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00707187
0220013701
No
Not Provided
Not Provided
James R. Seibold, Professor and Director, UMDNJ
University of Medicine and Dentistry of New Jersey
Not Provided
Not Provided
Rutgers, The State University of New Jersey
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP