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Clinical Trials/EUCTR2014-004729-42-DK
EUCTR2014-004729-42-DK
Active, not recruiting
Phase 1

The effect of testosterone replacement in patients with hypogonadotroph hypogonadism due to opioid treatment for non-malignant disease A double-blinded, randomized and placebo-controlled trial - NA

Odense University Hospital, department M0 sites40 target enrollmentFebruary 13, 2015
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DrugsNebido

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Odense University Hospital, department M
Enrollment
40
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 13, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Odense University Hospital, department M

Eligibility Criteria

Inclusion Criteria

  • •Male patients aged 18\-59 years
  • •Treatment with opioid for \>3 month, daily dose \> 50\-100 mg (for conversion see Annex 1\)
  • •Total testosterone \< 10 nmol/l
  • •FSH/LH levels normal or below normal laboratory values.
  • •Normal Prolactin levels
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 40
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •Hematocrit \> 54 % at screening
  • •PSA \> 3 ng/ml.
  • •Routine blood sample values above range (TSH, ionized calcium, hemoglobin, liver\- and kidney function tests)
  • •Severe organic or mental disease reasonably suspected from history and/or clinical examination
  • •Past or present breast or prostate cancer
  • •Past or present liver tumors or acute or chronic hepatic diseases
  • •Any current diagnosis of cancers
  • •Acute thrombotic or embolic diseases
  • •Previous VTE and Cerebrovascular disease
  • •Uncontrolled hypertension (SBP\>160mmHg and/or DBP\>100mmHg) despite adequate antihypertensive therapy

Outcomes

Primary Outcomes

Not specified

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