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Clinical Trials/EUCTR2008-001060-36-FR
EUCTR2008-001060-36-FRActive, not recruitingPhase 1

A Phase III open-label titration trial to evaluate the effectiveness and safety of different doses of a dermal application of Testosterone MD-Lotion® (cutaneous solution) in hypogonadal men

Acrux Pharma Pty Ltd0 sites150 target enrollmentStarted: October 20, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • •Patients who meet all of the following criteria may be entered into the trial:
  • •1.Male subjects greater than 18 years of age with a prior documented definitive diagnosis of hypoandrogenism as evidenced by previously documented:
  • •Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism,
  • •Screening serum testosterone of =300ng/dL (based on the average of two morning samples taken at least 30 minutes apart),
  • •2.Are currently receiving treatment (buccal, oral, transdermal or intramuscular androgen replacement) for hypoandrogenism in accordance with approved labeling, or in the Investigator’s opinion are eligible to receive such treatment,
  • •3.Body Mass Index (BMI) <35.0kg/m2,
  • •4.Haemoglobin levels at screening = 11.5g/dL,
  • •5.Adequate venous access on left or right arm to allow collection of a number of samples by venipuncture,
  • •6.Ability to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; willing to follow the Protocol requirements and comply with Protocol restrictions and procedures.
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients who meet any of the following criteria will not be eligible for participation in this trial:
  • •1.Current use of long acting testosterone injectables such as Nebido®,
  • •2.Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens,
  • •3.Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing that makes it undesirable for the Investigator to enrol the trial subject in the trial and/or that in the Investigator’s opinion, would interfere with the trial objectives or safety of the patient,
  • •4.Chronic skin disorder (eg. eczema, psoriasis) likely to interfere with transdermal drug absorption,
  • •5.Men with suspected reversible hypoandrogenism (i.e. due to medications, stress),
  • •6.Any man in whom testosterone therapy is contraindicated, which includes those with:
  • •-Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstruction and IPSS scores of =19,
  • •-Known or suspected carcinoma (or history of carcinoma) of the breast,
  • •-Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests >2 times the upper limit of the normal range values),
  • •-Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
  • •-Current significant cerebrovascular or coronary artery disease,
  • •-Untreated sleep apnoea,
  • •-Hematocrit of >51,
  • •-Untreated moderate to severe depression,
  • •7.Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (>4ng/mL), or age adjusted reference range of PSA values,
  • •8.Current or history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests > 2 times the upper limit of the normal range values),
  • •9.Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect SHBG or testosterone concentrations or metabolism, warfarin, insulin, opiates, GnRH, 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
  • •10.Men involved in sport in which there is screening for anabolic steroids,
  • •11.Men with uncontrolled diabetes (HbA1c=10%),
  • •12.Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives (whichever is the longer),
  • •13.Any contraindication to blood sampling,
  • •14.Subjects intending to have any surgical procedure during the course of the trial,
  • •15.Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial,
  • •16.Subjects whose partners are pregnant.

Investigators

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