A study in men with low testosterone to measure the effect of testosterone solution on testosterone levels, sex drive and energy.

Phase 1

Conditions: Male hypogonadism
MedDRA version: 14.1 Level: PT Classification code 10021011 Term: Hypogonadism male System Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-004866-16-GB

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 715

Inclusion Criteria

[1] Able to read, understand, and provide signed informed consent before starting trial activities related to Study TSAT (including discontinuing [washout] testosterone replacement therapy or other therapies prior screening). [2] Male at least 18 years of age at the time of screening. [3] Total testosterone level <300ng/dL (10.4 nmol/L) obtained at each of the 2 screening visits, performed at least 1 week apart (morning lab collection required between 0700 and 1100 hours). [4] Currently have at least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive, based on patient reported history and opinion of the investigator. [5] If the individual is taking lipid-lowering medications, insulin, antidepressants, anxiolytics, or therapy for benign prostatic hyperplasia (BPH), their dose must be stable for at least 3 months prior to screening in the opinion of the investigator. [6] PSA <4 ng/ml at the time of screening. [7] Agree to not start any new medication for erectile dysfunction (ED) or libido during the study at any point from screening to the end of the double-blind portion of the study (including herbal and over-the-counter medications). [8] If the individual is receiving testosterone replacement therapy and is willing to discontinue testosterone replacement therapy to enter the study, their screening testosterone level cannot be checked until at least 14 days after discontinuing oral or topical therapies (or at least 30 days for patients using short-acting intramuscular [IM] therapies [testosterone cypionate or testosterone enanthate] or at least 6 months for patients using long-acting IM testosterone undecanoate).
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 525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

Exclusion Criteria

[1] Sexual partner who is, or becomes, pregnant at any time during the study. [2] Use of long-acting IM testosterone undecanoate or testosterone pellets in the 6-month period prior to screening. [3] BMI >37kg/m2 at screening. [4] Severe lower urinary tract symptoms as well as significant prostate enlargement to the extent that the investigator does not believe that the patient should receive testosterone replacement therapy. [5] Prolactin lab test result of >30 ng/dL at screening. [6] HbA1c >11% at screening. [7] Hematocrit =50% at screening. For sites located at geographic elevations =4500 feet (approximately 1370 meters), patients will be excluded with hematocrit >54% at screening, according to investigator discretion. If any patient at any site regardless of geographic elevation develops hematocrit >54% at later study visits investigational product will be discontinued immediately. [8] Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens. [9] Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone. [10] Dermatologic condition in underarm area that might interfere with testosterone absorption or be exacerbated by topical testosterone replacement therapy. [11] Currently receiving treatment with cancer chemotherapy or antiandrogens. [12] Current use of systemic glucocorticoids. Use of non-testosterone anabolic steroids within 12 months prior to screening. [13] Competitive athletes involved in a sport in which they may be screened for anabolic steroids. [14] History of use of estrogenizing agents within 12 months prior to screening. [15] History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening. [16] History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening. [17] Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening. [18] Current use of warfarin. [19] History of frequent opioid use (>1 time/week) within 30 days prior to screening. [20] Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine). [21] History of drug, alcohol, or substance abuse within 6 months prior to screening, as assessed by the investigator. [22] Have a history of significant central nervous system injuries or disease within 6 months prior to screening. [23] Exhibit systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening, or have history of malignant hypertension. [24] History of unstable angina or angina occurring during sexual intercourse in the last 6 months. [25] History of any of the following coronary conditions within 90 days of screening: a. myocardial infarction b. coronary artery bypass graft surgery c. percutaneous coronary intervention (angioplasty or stent placement) [26] Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute [bpm]) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for =30 seconds), or use an automatic internal cardioverter-defibrillator. [27] Have a history of sudden cardiac arrest. [28] Exhibit any evidence of congestive heart failure within 6 months prior to screening. [29] Have had a new, significant cardiac conduction

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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