KEY TAKE-AWAYS ON REMOVAL OF BLACK BOX WARNING ON ADVERSE CV OUTCOMES FOR TESTOSTERONE THERAPY

[madman]

 

[madman]

Thread 'FDA issues class-wide labeling changes for testosterone products'

Feb 28, 2025

FDA issues class-wide labeling changes for testosterone products

FDA issues class-wide labeling changes for testosterone products

www.fda.gov

[2/28/2025] Today, FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial External Link Disclaimer and the results from required postmarket ambulatory blood pressure (ABPM) studies.

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• madman
• hypogonadism; t-therapy; cvd; fda
• Replies: 18
• Forum: Testosterone and Men's Health Articles

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[madman]

Thread 'Controversies with Testosterone Therapy - Management of Erythrocytosis and Elevated Estradiol'

Oct 12, 2025

Hot off the press!

25th Annual Fall Scientific Meeting of SMSNA!

Grapevine, Texas!

Great presentation!




1:29:40-1:43:30

Conclusions

• madman
• t-therapy; side effects; erythrocytosis; estradiol
• Replies: 35
• Forum: Testosterone Side Effect Management

 

[madman]

Thread 'TESTOSTERONE: A SAFETY UPDATE 2025'

Nov 16, 2025

Professor Michael Zitzmann

We also know hematocrit can be increased by testosterone preparations. It depends on the preparation, and we think that there is data that shows that the threshold of 52-54% should not be surpassed, and men should be controlled for the hematocrit especially in the first year of treatment every 3 months



Hematocrit & Thromboembolic Risk

* TTh increase Hematocrit - clinically relevant at >52-54%

* Recommended: Control Hematocrit every 3 months in the 1st year

...

• madman
• hypogonadism; testosterone; trt; cvd
• Replies: 24
• Forum: Testosterone and Men's Health Articles

 

[madman]

Thread 'EAU Guidelines on Male Sexual and Reproductive Health: 2025 Update on Male Hypogonadism, ED, Premature Ejaculation'

Nov 29, 2025

* Elevated haematocrit is common with TTh, typically occurring within 3–12 mo. Levels up to 54% appear safe, but higher values may increase CV risk [15].


* Treatment adjustments are required for haematocrit >54% (requiring withdrawal and phlebotomy in high-risk cases)

Fig. 1 – Diagnostic evaluation of late-onset hypogonadism. cFT = calculated free testosterone; LH = luteinising hormone; MRI = magnetic resonance imaging; PRL = prolactin; SHBG = sex hormone–binding globulin; T =...

• madman
• hypogonadism; eau guidelines; t-therapy; health
• Replies: 9
• Forum: Testosterone and Men's Health Articles