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Clinical Trials/ACTRN12615000071527
ACTRN12615000071527
Completed
Phase 4

Testosterone for Androgen Deficiency-Like Symptoms: A three phase, placebo-controlled, double-blind crossover study for males 40 years or older who believe they have androgen-like deficiency to assess whether testosterone gel treatment is superior to a placebo gel.

Department of Andrology, Concord Repatriation General Hospital0 sites40 target enrollmentJanuary 27, 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Department of Andrology, Concord Repatriation General Hospital
Enrollment
40
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Department of Andrology, Concord Repatriation General Hospital

Eligibility Criteria

Inclusion Criteria

  • Men aged 40 years or older
  • Believed to have androgen deficiency (AD)
  • Symptoms consistent with AD (according to US clinical guidelines)
  • Provides written, informed consent and is willing to comply with study requirements

Exclusion Criteria

  • Pathologically\-based AD
  • Major chronic illness causing serious disability or with life expectancy less then 2 years in the opinion of the investigator
  • Major cardiovascular event (new or worsened angina, infarction, angioplasty, uncontrolled arrhythmia or hypertension) within the last 6 months
  • Contraindication to testosterone including prostate or breast cancer.
  • History of androgen or other drug abuse within last year.
  • History of HIV or viral hepatitis.
  • Skin disease that may interfere with transdermal drug administration.
  • History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements.
  • Regular use of medications that interfere with absorption, metabolism or action of testosterone and may require dosage change during the study.
  • Haematocrit over 0\.50 or history of polycythaemia

Outcomes

Primary Outcomes

Not specified

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