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Serum testosterone before and during treatment with oral testosterone undecanoate in patients with central hypogonadism.
Source publication
Introduction. This study evaluates the clinical efficacy of androgen replacement therapy with the new long-acting intramuscular (i.m.) testosterone undecanoate (T.U.) in comparison to oral T.U. in adult men with hypogonadotropic hypogonadism. Patients and methods. In 41 patients with central hypogonadism (30 with pituitary tumors or craniopharyngio...
Contexts in source publication
Context 1
... group A, T increased significantly on oral T.U. treatment from 0.37 ± 0.40 ng/mL to 1.43 ±1.36 ng/mL (range 0-6.21), p<0.01, but only 4 patients out of 28 (14%) had values within the normal range ( Fig. 1). None had unphysiologically high ...
Context 2
... absorption pattern and results in peaks and valleys of serum testosterone levels throughout the day, with high inter-and intraindividual variability (1,3,11). However, the dosing flexibility and the convenience of oral administration made some of our patients prefer this formulation. ...
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Citations
Although multiple forms of testosterone replacement therapy are available to treat hypogonadism, none is ideal. This article reports on the pharmacokinetics of an innovative nasal formulation of testosterone in hypogonadal men. The first study was undertaken in eight men with a baseline total testosterone (TT) of 130.8 +/- 87.4 ng/dL and examined the pharmacokinetics of nasal testosterone given in a single dose of 7.6 mg, 15.2 mg or 22.8 mg, respectively. The second study examined the pharmacokinetics of nasal testosterone (7.6 mg) given either twice or three times a day in 21 severely hypogonadal men (baseline TT in 20 patients <50 ng/dL, in one patient 152 ng/dL) for 14 days. The steady-state concentration of testosterone was within the normal range in all treatment groups, but only in the 3-times-a-day group was the 95% confidence interval completely within the physiological range. The average DHT level did not exceed the upper range of normal. The clinical global visual analogue scale improved in the whole group receiving testosterone (p < 0.001). All adverse events in both studies were of mild to moderate intensity and were evaluated as unlikely or not related to the administered study drug. No patients dropped out during treatment. Comparison with the normal circadian rhythm by computer modelling suggests that nasal testosterone can be used to mimic the normal diurnal pattern in eugonadal men. Thus, nasal testosterone can be administered safely to humans in doses that approximate serum concentrations in the normal physiological range.
