Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction - Full Text View

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00707187

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 II

MedlinePlus related topics: Scleroderma

Drug Information available for: Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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

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
1: Experimental 35 doses of study medication, IC 351 (20 mg) -- crossover to placebo	Drug: Cialis 35 pills of study medication (20 mg)
2: Experimental 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

Responsible Party:	UMDNJ ( James R. Seibold, Professor and Director )
Study ID Numbers:	0220013701
Study First Received:	June 25, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707187
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

Study placed in the following topic categories:

Peripheral Vascular Diseases
Raynaud Disease
Skin Diseases
Tadalafil
Vascular Diseases

Connective Tissue Diseases
Neoplasm Metastasis
Sclerosis
Scleroderma, Systemic

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009