Male Hypogonadism MedDRA version: 9.1 Level: LLT Classification code 10021011 Term: Hypogonadism male
Conditions
Interventions
Product Name: Testosterone 2% Cutaneous Solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: TESTOSTERONE
CAS Number: 58220
Concentration unit: % (W/V) percent weight/volume
Concentra
Sponsors
Acrux Pharma Pty Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the current trial is to confirm the formulation and safety of four doses of Testosterone 2% Cutaneous Solution for use by hypogonadal men via the axilla that may be taken to market. In addition, the trial will aim to achieve a Cavg for total testosterone in the defined normal range (300-1050ng/dL).;Secondary Objective: ;Primary end point(s): Proportion of subjects with Cavg (0-24h) total testosterone within the normal range (300–1050ng/dL) at Day 120. | — |
Countries
France, Germany, Sweden, United Kingdom
Outcome results
None listed