Ambulatory Blood Pressure Parameters Among Men With Hypogonadism Treated With Testosterone Transdermal Therapy.

The primary noninferiority endpoint was not met, as the upper bound of the 95% CI for mean change in 24-hour systolic BP exceeded the 3.0 mmHg threshold.

• Mean change from baseline to week 16 in 24-hour average SBP was 3.5 mmHg (95% CI, 1.2–5.8 mmHg; n = 62)
• Noninferiority was defined as the upper bound of the 2-sided 95% CI < 3.0 mmHg
• The upper limit of the CI was >3 mmHg, so 'an effect of TTS could not be ruled out'
• 62 men had ≥85% study drug compliance and a valid week 16 ambulatory BP monitoring session

Mean changes in systolic blood pressure were larger during daytime compared to nighttime.

• Daytime vs nighttime differences in mean SBP changes were observed across the 16-week treatment period
• This pattern was noted as part of the 24-hour ambulatory BP monitoring analysis
• Specific daytime and nighttime values are referenced in the abstract but not numerically broken down beyond the directional finding

Men with hypertension at baseline showed larger mean changes in systolic blood pressure compared to men without hypertension.

• Subgroup analysis compared men with vs without hypertension
• Greater BP increases were observed in the hypertension subgroup
• This subgroup finding was noted as part of secondary analyses of the 24-hour ambulatory BP monitoring data

Cardiovascular adverse events were rare and nonserious, with no major cardiovascular adverse events reported.

• Cardiovascular adverse events occurred in <2% of participants
• No major cardiovascular adverse events were reported during the 16-week treatment period
• 168 men were enrolled and received ≥1 study drug dose (mean age: 56.2 years)

The study enrolled men with hypogonadism not receiving testosterone replacement therapy and administered nightly testosterone transdermal system for 16 weeks.

• Single-arm, noninferiority trial conducted at 41 US sites
• 168 men enrolled with mean age 56.2 years
• Starting dose was 4 mg/d with minimum 2 mg/d and maximum 6 mg/d
• Target testosterone concentration was 400–930 ng/dL
• Participants had not received testosterone replacement therapy in the past 6 months