The chronic treatments of PDE-5 inhibitors in ED patients improve testosterone levels and oxdative status: the comparison of Sidenafil with Tadalafil.

UMIN ID: UMIN000000986

Registered date:30/01/2008

Basic Information

• Health condition(s) or Problem(s) studied: Erectile and endothelial dysfunction are common pathologies of multiple cardiovascular risk factors and are considered longitudinal predictors of cardiovascular events. Oxidative stress and decreases in testosterone levels play an important role in the pathogenesis of endothelial dysfunction.
• Date of first enrollment: 2008/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Regular intake of Sildenafil 50mg once a week
Regular intake of Tadanafil 20mg once a week

Outcome(s)

• Primary Outcome: IIEF-EF scores are used to assess ED severity. Antioxidant status is defined by salivary 8-OHdG. Salivary testosterone is used to evaluate serum bioavailable testosterone availability.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 70years-old
• Gender: Male
• Exclude criteria: Subjects with kidney disease, liver failure, coronary heart disease, peripheral or cerebrovascular disease, endocrine diseases, prostatic disease, and major psychiatric disorders, except depression, were excluded. Patients concomitantly treated with nitrates or with congestive heart failure or those who were prescribed medicines that might modulate testosterone metabolism were also excluded.

Related Information

• Primary Sponsor: Teikyo University, School of Medicine, Department of Urology
• Source(s) of Monetary Support: Teikyo University, School of Medicine