| Eligibility |
Inclusion Criteria:
1. Adult male whose age is between 18 and 80 years, inclusive, at the time of screening.
2. Considered by the investigator to be in good general health as determined by medical
history, clinical laboratory test results, vital sign measurements, 12-lead
electrocardiogram (ECG) results, and physical examination findings at screening.
3. Meets the study definition of clinical hypogonadism, as evidenced by serum
testosterone concentrations:
1. Two serum testosterone concentrations < 300 ng/dL collected in the morning
(between 0630 hours and 1000 hours local time) on at least 2 days separated by a
minimum of 48 hours.
2. Presence of at least 1 sign or symptom that may be related to low testosterone
values and is/are consistent with hypogonadism
4. Naïve to testosterone replacement, clomiphene, compounded or over-the-counter
androgenic steroid derivatives and dehydroepiandrosterone, including investigational
products that may affect the reproductive hormonal system within the past 2 months.
5. Willingness and the ability to apply topical testosterone gel as instructed by the
study staff and comply with the requirements of this study protocol.
6. Intact skin surfaces on the upper arms and shoulders where the topical testosterone
will be applied.
Exclusion Criteria:
1. Two testosterone concentrations < 100 ng/dL during screening.
2. Prolactin concentration > 1 x upper limit of normal (ULN).
3. Current or recurrent ulcer, erosion, lichenification, inflammation psoriasis, eczema
or use of topical corticosteroids on the upper arms and shoulders. Tattoo application
or removal in the region of study drug application.
4. Known skin intolerance to alcohol or allergy to any of the ingredients of the study
drug.
5. History of treatment with growth hormone, anti-estrogen or estrogen treatment within
90 days prior to screening.
6. Currently taking glucocorticoids > 7.5 mg prednisone equivalent per day (eg,
hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) for 1 week
before SV1 and through Day 1, and any use of opioids within 5 half-lives prior to Day
1.
7. Currently taking, unstable doses within 14 days prior to first administration of study
drug or anticipated to receive any antihypertensive medications, over-the-counter
medications, supplements or herbal medicines known to affect blood pressure during
study participation. These medications or supplements include diet pills (eg,
phenylpropanolamine, sibutramine), nasal decongestants (eg, phenylephrine
hydrochloride, pseudoephedrine, naphazoline hydrochloride), certain stimulants (eg,
amphetamine, methylphenidate dexmethylphenidate, dextroamphetamine), monoamine oxidase
inhibitors (MAO), atypical antipsychotics (eg, clozapine, olanzapine).
8. History of prostate (current or in the past) or breast cancer.
9. Severe lower urinary tract symptoms as indicated by an International Prostate Symptom
Score (I-PSS) > 19.
10. Prostate-specific antigen (PSA) > 3.0 ng/mL; men treated with 5-alpha reductase
inhibitors (eg, dutasteride, finasteride) are eligible for participation as long as
PSA levels are not > 1.5 ng/mL.
11. Body mass index > 50 kg/m2.
12. Sitting SBP < 80 mm Hg and > 150 mm Hg or sitting DBP < 50 mm Hg and > 100 mm Hg at
any point during screening.
13. HbA1c > 11% at screening.
14. A current condition, therapy, laboratory abnormality, history of clinically
significant medical or psychiatric conditions or other circumstance or reasons which,
in the opinion of the investigator or the study staff, might pose a risk to the
subject, make participation not in the subject's best interest, confound the results
of the study (eg, if subject cannot comply with requirements of the study), make the
subject an unsuitable candidate to receive study drug, or interfere with the subject's
participation for the full duration of the study.
15. History, suspicion, or evidence of significant drug or alcohol abuse or illicit
steroid use within the previous 12 months prior to screening, as determined by the
investigator.
16. The subject is a smoker or has used nicotine or nicotine-containing products (eg,
snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6
months before the first dose of study drug.
17. Clinical laboratory analysis shows any of the following abnormal results:
- Hematocrit > 50%
- Alanine aminotransferase or aspartate aminotransferase > 3 × ULN
18. Severe or end-stage chronic kidney disease documented by eGFR < 30 mL/min.
19. Subject works night shifts.
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