Phase 3
Completed N=155
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Source: ClinicalTrials.gov NCT00702650 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Jan 2011
Primary outcomePrimary: Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 — 84.1 percentage of participants — p=<0.001
Summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120 |
84.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL |
5.2 | — |
| SECONDARY Percentage of Participants With Cmax Between 1800 and 2500 ng/dL |
3.0 | — |
| SECONDARY Percentage of Participants With Cmax >2500 ng/dL |
0.7 | — |
| SECONDARY Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL |
64.4 | — |
| SECONDARY Change From Baseline to Endpoint in Psychosexual Daily Questionnaire |
1.49; 0.94; 1.11; 0.56; -0.50 | <0.0001 sig |
| SECONDARY Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36) |
1.55; 4.54 | 0.0254 sig |
| SECONDARY Change From Baseline to Endpoint in Fasting Insulin |
1.93 | — |
| SECONDARY Change From Baseline to Endpoint in Fasting Glucose |
-0.41 | — |
| SECONDARY Change From Baseline to Endpoint in Prostate Specific Antigen (PSA) |
0.13 | — |
| SECONDARY Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) |
-2.04; -2.41 | — |
| SECONDARY Change From Baseline to Endpoint in Estradiol |
-2.16 | — |
| SECONDARY Change From Baseline to Endpoint in Haemoglobin |
0.51 | — |
| SECONDARY Change From Baseline to Endpoint in Haematocrit |
0.02 | — |
| SECONDARY Change From Baseline to Endpoint in Draize Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male subjects with a prior documented definitive diagnosis of hypogonadism as evidenced by previously documented:
- Hypothalamic, pituitary or testicular disorder or age related idiopathic hypogonadism
- Screening serum testosterone of less than or equal to 300 ng/dL (based on the average of two morning samples taken at least 30 minutes apart)
- Were currently receiving treatment for hypogonadism in accordance with approved labelling, or in the Investigator's opinion are eligible to receive such treatment
- Body Mass Index (BMI) 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
- Haematocrit of > 51
- Untreated moderate to severe depression
- Men with clinically significant prostate exam (such as irregularities or nodules palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA) levels (>4 ng/mL), or age adjusted reference range of PSA values
- 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)
- Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
- Men involved in sport in which there is screening for anabolic steroids
- Men with uncontrolled diabetes (haemoglobin A1c [HbA1c] greater than or equal to 10%)
- Men currently taking any investigational product, or have received an investigational product within 28 days prior to screening or 5 half-lives
- Any contraindication to blood sampling
- Subjects intending to have any surgical procedure during the course of the trial
- Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
- Subjects whose partners are pregnant
Data sourced from ClinicalTrials.gov (NCT00702650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.