A Study to Evaluate Androderm's Effect on Blood Pressure in Adult Hypogonodal Male Participants.

• Status: Completed
• Trial end date: 2021-06-24
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the effect of a once daily Androderm dose on Blood Pressure (BP) in adult hypogonadal men as measured by 24-hour ABPM

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and DHEA, including investigational products that may affect the reproductive hormonal system or has not been treated with these compounds in the past 6 months

• Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period

• Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent

• BMI < 35 kg/m2

• Male

Exclusion Criteria:

• Uncontrolled systemic disease or clinically significant disease, in particular, liver, kidney or heart disease, including hypertension, congestive heart failure, coronary heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that in the investigator's opinion, would put the participant at an unacceptable risk with exposure to Androderm.

• History of prostate (current or in the past) or breast cancer

• Had a recent (within 2 years) history of stroke, transient ischemic attack, acute coronary event, venous thrombotic, or thromboembolic event

• History of alcohol or other substance abuse within the previous 2 years

• Known allergy or sensitivity to the study intervention or its components or other testosterone replacement medications

• Participant who works night shifts or who will need to perform strenuous manual labor while wearing the ABPM monitor