ACTRN12610000144011CompletedPhase 4
The effect of Continuous Positive Airway Pressure (CPAP) on Erectile and Endothelial Dysfunction in Impotent men with Obstructive Sleep Apnoea (OSA)
HMRC0 sites61 target enrollmentStarted: February 12, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 61
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- Male
Inclusion Criteria
- •Males aged 18-65 with moderate to severe obstructive sleep apnoea (respiratory disturbance index >20), erectile dysfunction (International Index of Erectile Function (IIEF) <26) and in a stable heterosexual relationship for at least 6 months
Exclusion Criteria
- •Patients will be excluded if they require immediate treatment for obstructive sleep apnoea due to severity or increased associated risk, are suffering from any uncontrolled concurrent medical or psychiatric illness, or that may cause a drug interaction with vardenafil; has medical conditions that would contraindicate administration of vardenafil (eg, severe renal or hepatic impairment) or has irregular sleep patterns, such as shift-workers.
Investigators
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