KEY TAKE-AWAYS ON REMOVAL OF BLACK BOX WARNING ON ADVERSE CV OUTCOMES FOR TESTOSTERONE THERAPY
- Thread starter madman
- Start date
Share this page
madman
Super Moderator
FDA issues class-wide labeling changes for testosterone products
FDA issues class-wide labeling changes for testosterone products
[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.
Led by the...
madman
Super Moderator
Hot off the press!
25th Annual Fall Scientific Meeting of SMSNA!
Grapevine, Texas!
Great presentation!
1:29:40-1:43:30
Conclusions
25th Annual Fall Scientific Meeting of SMSNA!
Grapevine, Texas!
Great presentation!
1:29:40-1:43:30
Conclusions
madman
Super Moderator
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
...
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
Super Moderator
* 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 =...
* 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 =...
ExcelMale Newsletter Signup
Similar threads
Sponsors
Share this page
Online statistics
- Members online
- 3
- Guests online
- 392
- Total visitors
- 395
