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

Allergan

Status and phase: Completed; Phase 4

Conditions: Hypogonadism

Treatments: Drug: Androderm®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04320745

3146-402-016

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naïve to testosterone replacement, clomiphene, compounded or over-the-counter androgenic steroid derivatives, and dehydroepiandrosterone (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
• Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Androderm® 4 mg

Experimental group

Description:

Participants received Androderm® 4 mg, transdermal dose, once daily (QD) for up to 16 weeks. At Day 14, if serum concentration was less than 400 nanograms per deciliter (ng/dL), the dose was increased to 6 mg, transdermal dose, QD for up to 16 weeks and if the serum concentration was more than 930 ng/dL, the dose was decreased to 2 mg, transdermal dose, QD for up to 16 weeks. The dose was not adjusted if serum concentrations were within the normal range.

Treatment:

Drug: Androderm®