Time to Eugonadal Range, Time to Steady State and Drying Time

Inclusion Criteria

• Men aged 18 to 65 years.
• Have a diagnosis of primary or secondary hypogonadism with a:
• Single morning serum total testosterone concentration 2.5 × ULN (upper limit of normal).
• Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the subject's suitability for the trial.
• History of, or any existing, clinically significant cardiac disease (New York Heart Association [NYHA] Class III and IV).
• Clinically significant electrocardiogram (ECG) abnormalities such as QTcB or QTcF ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block.
• Prostate specific antigen (PSA) level >4 ng/mL.
• An abnormality on digital rectal examination deemed to be suspicious or worrisome for cancer, such as a nodule or asymmetric induration.
• Severe symptomatic benign prostatic hyperplasia or International Prostate Symptom Score (IPSS) >19 (at screening).
• Sleep apnea which is untreated, or subjects with sleep apnea which is treated (including c-PAP treatment) but in the opinion of the investigator has been clinically unstable during the 3 months prior to screening.
• Current eczema, psoriasis, sunburn, or any other clinically significant skin condition at the application site.
• Current abrasions at site of application.
• Malignancy (or suspected malignancy) of any type except a basal cell carcinoma. Subjects with a history of malignancy must have a disease free status ≥5 years prior to starting study treatment. Subjects who have had prostate or breast cancer are not permitted to participate in the study.
• Known to be sensitive and/or has had an adverse skin reaction to testosterone hormone replacement therapy or topical products containing alcohol.
• Actively or potentially trying to start a family or requiring fertility treatment or with a spouse/partner who is pregnant.
• Participated in any experimental drug or device study within 30 days prior to starting study treatment.
• History of alcohol or substance abuse within the last year.
• Taking opioids for any reason within 3 days of screening
• Receiving the following medications:
• Androgen treatments.
• Androgen antagonists.
• Application of any lotions, ointments, or steroids to the application site.
• 5alpha-reductase inhibitors (eg, finasteride, dutasteride).
• Any subjects receiving testosterone hormone replacement treatments must abide by the indicated washout period prior to screening total serum testosterone measurement