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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00707187

Enrollment

120

Registered

2008-06-30

Start date

2001-07-31

Completion date

2002-07-31

Last updated

2008-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

systemic sclerosis, scleroderma, raynaud phenomenon

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

Interventions

DRUGCialis

35 pills of study medication (20 mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of Raynaud attacks	16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026