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

Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707187
• Other study ID #: 0220013701
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2008
• Last updated: June 27, 2008
• Start date: July 2001
• Est. completion date: July 2002

Study information

• Verified date: June 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Cialis
35 pills of study medication (20 mg)

Locations

Country	Name	City	State
United States	UMDNJ	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Raynaud attacks		16 weeks	No