Stress Management Using an App to Improve Response With PDE5 Inhibitors in Men With Erectile Dysfunction.

Status unconfirmed · Not applicable

Conditions studied: Erectile Dysfunction

In brief

The aim of this study is to determine if patients with ED taking PDE5 inhibitors (e.g. Viagra, CIalis, Levitra, Stendra) and experiencing performance anxiety will benefit using a user-friendly stress reducing phone app, Serenita. The study is internet based with no office visits.

Key facts

Study ID

NCT02757807

Run by

Eco Fusion

People needed

100

Starts

2016-07-01

Expected to finish

2016-12-01

Last updated by the study team

2016-07-20

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male ages 18-55 years old
• Persistent mild to moderate ED on PDE5 inhibitors (Viagra, Cialis, Levitra, Stendra)
• Understand English
• Owns smartphone using either iPhone or Android
• Able to understand the use of "Serenita" app
• Willing to use Serenita app before sexual attempt
• Willing to complete all study questionnaires Willing to perform sexual attempt for at least once a week until end of study.

You may not qualify if…

• On testosterone replacement therapy
• History of Peyronie's disease
• Significant cardiac history (uncontrolled hypertension, cardiac arrhythmia, coronary artery disease, coronary bypass surgery)
• Uncontrolled diabetes mellitus
• History of prostate cancer
• Poorly controlled, symptomatic, active medical problems (HIV, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder)
• Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol

Where it is running

• RMA — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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