Vogelxo(R) ABPM Study in Hypogandal Men

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.