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

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cialis
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring systemic sclerosis, scleroderma, raynaud phenomenon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UMDNJ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Raynaud attacks

Secondary Outcome Measures

Full Information

First Posted
June 25, 2008
Last Updated
June 27, 2008
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00707187
Brief Title
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
July 2002 (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
systemic sclerosis, scleroderma, raynaud phenomenon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
Arm Title
2
Arm Type
Experimental
Arm Description
35 placebo pills followed with 35 study medication (20 mg)
Intervention Type
Drug
Intervention Name(s)
Cialis
Intervention Description
35 pills of study medication (20 mg)
Primary Outcome Measure Information:
Title
Number of Raynaud attacks
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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