Testosterone and “Age-Related Hypogonadism” — FDA Concerns  

Oleh:

Nguyen, Christine P. ; Hirsch, Mark S. ; Moeny, David ; Kaul, Suresh ; Mohamoud, Mohamed

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 373 no. 08 (Aug. 2015), page 689-691.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Testosterone products have been approved by the Food and Drug Administration (FDA) for replacement therapy in men with “classic hypogonadism” — primary or secondary hypogonadism caused by specific, well-recognized medical conditions, such as Klinefelter's syndrome, pituitary injury, or toxic damage to the testicles.1 Treatment with testosterone to restore serum concentrations in men with classic hypogonadism has long been considered the standard of care. On the basis of this intended use, the FDA has required only that testosterone products reliably bring low serum testosterone concentrations into the normal range, defined as the concentrations seen in healthy young men. The FDA has not mandated that clinical trials show improvements in signs or symptoms of hypogonadism in order for a testosterone product to be approved.

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