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Clinical Trials/EUCTR2008-001459-23-GB
EUCTR2008-001459-23-GB
Active, not recruiting
Not Applicable

Treatment of Testosterone deficiency in men with Sleep Apnoea Syndrome utilising Nebido therapy.

ikolai Sleep Monitoring Clinic0 sitesJune 18, 2008
DrugsNebido

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ikolai Sleep Monitoring Clinic
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ikolai Sleep Monitoring Clinic

Eligibility Criteria

Inclusion Criteria

  • 20 hypogonadal men requiring Nebido therapy who have proven sleep apnoea syndrome
  • Hypogonadism is defined as:
  • Total testosterone of \<8 nmol or free testosterone of \< 180 pmol/L
  • Total testosterone between 8\-12 nmol/L or free testesterone .180\-250 pmol/L who are symptomatic of hypogonadism:
  • \- Diminished libido and erectile quality and frequency
  • \-Changes in mood and cognitive ability
  • \-Sleep disturbance
  • \-Decrease in lean body mass
  • \-Increase in visceral fat
  • \-Decrease in body hair and skin alterations

Exclusion Criteria

  • The patients are ineligible for the study if there is a current or past history of:
  • \- Androgen dependent carcinoma of prostate or male mammary galnd
  • \-Liver tumours
  • \-Hypersensitivity to Nebido or any of its incipients
  • \-Symptoms or signs of prostatic enlargement
  • \-Polycythaemia (Haematocrit of 55% or more)
  • \-Any general systemic illness
  • \-Severe cardiac, hepatic or renal insufficiency
  • or those deemed unable to comply with the requirements of the protocol

Outcomes

Primary Outcomes

Not specified

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