Active Ingredients: Clomiphene
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Biological rhythms dominate reproductive hormone release in both males and females. Patients with this hypothalamic defect have helped elucidate the feedback control of sex steroids at the level of the pituitary and the hypothalamus and to identify additional defects.
At the level of the hypothalamus, pituitary and testes there is a clear rhythm that results in the testicular production of testosterone in males, with healthy young men experiencing a morning peak, a trough in the early evening, followed by a gradual increase towards the morning peak.
In most ageing men there is an overall decrease in testosterone levels and a blunting in circadian androgen levels, perhaps caused by the disruption of feedback and feed-forward control mechanisms.
Oestrogens have also been shown to play a role in these feedback processes in men. In most studies with transdermal testosterone the determination of serum levels of total testosterone constitutes pharmacokinetics.
In the present study, treatment with oral enclomiphene citrate constitutes pharmacodynamics. In an early phase II study we evaluated the potential of oral enclomiphene citrate to increase serum testosterone levels in 52 men with secondary hypogonadism.
Men who had low total testosterone values at baseline had significant increases in serum total testosterone levels after 2 weeks of treatment with enclomiphene citrate.
A more recent study provided evidence that enclomiphene citrate raises testosterone levels in men with secondary hypogonadism and also preserves or improves sperm counts. In contrast to the group receiving enclomiphene citrate, men receiving Testim had a reduction in LH and FSH levels and in sperm counts.
Patients and Methods Patients Forty-eight men were randomized to receive either: 6. These men were defined as the intent-to treat ITT population. Four men three in the enclomiphene citrate 12.
Forty-four subjects completed the study per protocol PP and were defined as the PP population. The mean sd BMI for all men was 34.
There was no significant difference in age or BMI among the treatment groups.
Others variables were determined by standard laboratory methods.