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

NCT ID: NCT00707187

Last Updated: 2008-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2002-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Systemic Sclerosis

Keywords

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systemic sclerosis scleroderma raynaud phenomenon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

35 doses of study medication, IC 351 (20 mg) -- crossover to placebo

Group Type EXPERIMENTAL

Cialis

Intervention Type DRUG

35 pills of study medication (20 mg)

2

35 placebo pills followed with 35 study medication (20 mg)

Group Type EXPERIMENTAL

Cialis

Intervention Type DRUG

35 pills of study medication (20 mg)

Interventions

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Cialis

35 pills of study medication (20 mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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UMDNJ

Locations

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UMDNJ

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0220013701

Identifier Type: -

Identifier Source: org_study_id