Measuring the testosterone levels and adjusting the administered exogenous testosterone means the study was not blinded, may that lead to assessment biases?
It was double blinded. The study design included several features to maintain blinding: participants received either daily transdermal 1.62% testosterone gel or matching placebo gel in identical metered-dose pumps, and sham dose adjustmentswere made in the placebo group to mirror the titration protocol used in the testosterone gel group. To prevent unblinding, both patients and the trial team remained unaware of post-baseline testosterone levels measured at the central laboratory NEJM.
Many women as they age have very little testosterone, blood work shows almost non existent levels. It has been stated the using a low dose of testosterone gel for women could be beneficial to how they are feeling overall. Is it safe for women and does it have any effect on cardiovascular functioning, or have all the tests been on men. Thank you
He certainly entitled to his opinion and that’s why it’s an editorial, but I have to defer to the New England Journal of Medicine Editorial Review Board.
I looked at this editorial and at the study in which the author was the lead author that he references that was published in 2017. The last sentence in the conclusion of that study was that it wasn’t long enough or large enough to draw any conclusions. It seems to me that his editorial may be sour grapes.
Budhoff was not the principal investigator. He was giving an opinion that was refuted.
Despite these criticisms, the trial's noninferiority conclusion has been widely supported by subsequent analyses and guideline bodies:
The 2024 AHA/ASA stroke prevention guideline issued a Class 2a recommendation that testosterone replacement therapy is reasonable and does not increase stroke risk in men 45–80 years with confirmed hypogonadism, citing TRAVERSE as the pivotal evidence.
The Androgen Society position paper (2024) concluded that testosterone therapy is not associated with increased risks of heart attack, stroke, or cardiovascular death based on TRAVERSE and prior evidence.
Yeap et al. (2026) in The Journal of Clinical Endocrinology and Metabolism noted that TRAVERSE "demonstrated cardiovascular safety of testosterone treatment" in men with CVD or multiple risk factors.
The TRAVERSE investigators addressed the high discontinuation rates in multiple substudy publications, noting that sensitivity analyses censoring follow-up 30 days and 365 days after treatment discontinuation yielded similar results, and that nonretention rates were similar between arms and consistent with other chronic symptomatic conditions
Great content! info that I'm highly interested in. Because I want a better quality of life. And an extended life if possible. i think that's why we're all here. Thank you.
Measuring the testosterone levels and adjusting the administered exogenous testosterone means the study was not blinded, may that lead to assessment biases?
It was double blinded. The study design included several features to maintain blinding: participants received either daily transdermal 1.62% testosterone gel or matching placebo gel in identical metered-dose pumps, and sham dose adjustmentswere made in the placebo group to mirror the titration protocol used in the testosterone gel group. To prevent unblinding, both patients and the trial team remained unaware of post-baseline testosterone levels measured at the central laboratory NEJM.
I love the Freudian slip! Men who are too virile may actually be viral (HIV).
Many women as they age have very little testosterone, blood work shows almost non existent levels. It has been stated the using a low dose of testosterone gel for women could be beneficial to how they are feeling overall. Is it safe for women and does it have any effect on cardiovascular functioning, or have all the tests been on men. Thank you
I am wondering what your opinion is of Dr. Budoff’s article? https://pmc.ncbi.nlm.nih.gov/articles/PMC11198716/
He certainly entitled to his opinion and that’s why it’s an editorial, but I have to defer to the New England Journal of Medicine Editorial Review Board.
I looked at this editorial and at the study in which the author was the lead author that he references that was published in 2017. The last sentence in the conclusion of that study was that it wasn’t long enough or large enough to draw any conclusions. It seems to me that his editorial may be sour grapes.
Budhoff was not the principal investigator. He was giving an opinion that was refuted.
Despite these criticisms, the trial's noninferiority conclusion has been widely supported by subsequent analyses and guideline bodies:
The 2024 AHA/ASA stroke prevention guideline issued a Class 2a recommendation that testosterone replacement therapy is reasonable and does not increase stroke risk in men 45–80 years with confirmed hypogonadism, citing TRAVERSE as the pivotal evidence.
The Androgen Society position paper (2024) concluded that testosterone therapy is not associated with increased risks of heart attack, stroke, or cardiovascular death based on TRAVERSE and prior evidence.
Yeap et al. (2026) in The Journal of Clinical Endocrinology and Metabolism noted that TRAVERSE "demonstrated cardiovascular safety of testosterone treatment" in men with CVD or multiple risk factors.
The TRAVERSE investigators addressed the high discontinuation rates in multiple substudy publications, noting that sensitivity analyses censoring follow-up 30 days and 365 days after treatment discontinuation yielded similar results, and that nonretention rates were similar between arms and consistent with other chronic symptomatic conditions
Great content! info that I'm highly interested in. Because I want a better quality of life. And an extended life if possible. i think that's why we're all here. Thank you.