FindTrial
Sign In

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001459-23-GB
Enrollment
Unknown
Registered
2008-06-18
Start date
2008-06-24
Completion date
Unknown
Last updated
2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnoea Hypogonadism- testosterone deficiency syndrome MedDRA version: 9.1 Level: LLT Classification code 10021011 Term: Hypogonadism male MedDRA version: 9.1 Level: LLT Classification code 10040977 Term: Sleep apnoea

Interventions

Trade Name: Nebido Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: TESTOSTERONE UNDECANOATE CAS Number: 5949440 Concentration unit: mg/ml milligram(s)/millilitre Conc

Sponsors

Nikolai Sleep Monitoring Clinic
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 20 hypogonadal men requiring Nebido therapy who have proven sleep apnoea syndrome Hypogonadism is defined as: Total testosterone of =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the effects of NEBIDO therapy for hypogonadism on the parameters of sleep apnoea syndrome;Secondary Objective: To determine the effect of NEBIDO therapy on symptoms of hypogonadism such as dimished libido, erectile quality, mood changes, waist circumference and Body Mass Index To find out the tolerability of NEBIDO therapy in patients with sleep apnoea syndrome when given in physiological doses. ;Primary end point(s): -Improvement of daytime sleepiness by assessing the patient employing the Epworth Sleepiness Scale (before and after treatment) -Incidence of oxyhaemoglobin desturation dips of 4% or lower per hour -The sleep apnoea index (number of events per hour)—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026