Reproductive endocrinology

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

Endocr PractPublished Single-arm trial

Authors' conclusion

A meaningful effect of 16-week TTS treatment on 24-hour average SBP among men with hypogonadism could not be ruled out based on the study's noninferiority criterion. The magnitude of mean changes observed may not be clinically meaningful regarding cardiovascular events.

Study context

Population
Men (mean age 56.2 years) with hypogonadism not receiving testosterone replacement therapy in the past 6 months, 41 US sites62 analysed
Participants
168 men
Outcome
Mean change from baseline in 24-hour SBP (24-hour ambulatory blood pressure (BP) monitoring)
Follow-up
Week 16
Methodological detailsnoninferiority, multicentre
  • Noninferiority
  • Multicentre

Main finding

As reported in the abstract

Mean change from baseline in 24-hour average SBP

Mean change from baseline to week 16 in 24-hour average systolic BP (SBP)

3.5 mmHg

95% CI 1.2–5.8 mmHg; n = 62

Further findings

SBP change by time of day and hypertension subgroup · week 16

Mean changes larger at daytime vs nighttime and in men with vs without hypertension

Safety

Cardiovascular adverse events, rare and nonserious
<2%
Major cardiovascular adverse events
0

Original publication

Ambulatory Blood Pressure Parameters Among Men With Hypogonadism Treated With Testosterone Transdermal Therapy. Endocr Pract. Published 12 June 2024. doi:10.1016/j.eprac.2024.05.015

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