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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

Page last updated: August 20, 2015

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