Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00893191
First received: May 3, 2009
Last updated: May 4, 2009
Last verified: May 2009

May 3, 2009
May 4, 2009
May 2009
Not Provided
apnea hypopnea index after sildenafil vs. placebo [ Time Frame: Hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo [ Time Frame: hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
50 healthy males aged 40 - 65 years
  • Sildenafil
  • Sleep Apnea
  • Sexual Dysfunction
  • Obesity
Not Provided
  • Sildenafil
    Treated with 50 mg of Sildenafil at night
  • Placebo
    Treated with placebo at night
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Not Provided
Not Provided

Inclusion Criteria:

  • Age - 40-65 years
  • BMI equal to or over 30

Exclusion Criteria:

  • A known cardiorespiratory, liver or kidney disease
  • Treatment with nitrates or alfa blockers
  • Performed polysomnography in the past
Male
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00893191
39/09
Not Provided
Not Provided
Not Provided
Isaac Shpirer, Asaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Not Provided
Assaf-Harofeh Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP