Phase 3
N=155
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT00702650 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Jan 2011
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone MD-Lotion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2009
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 |
— | — |
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.
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.