Additionally, estradiol levels rose substantially on clomiphene but remained stable with enclomiphene. One study reported adverse events in 18.18% of men taking clomiphene, compared to just 3.45% of those on enclomiphene . In contrast, zuclomiphene has estrogen-like effects and a longer half-life, which may contribute to unwanted side effects over time. Enclomiphene is the active component that stimulates testosterone production. The effects of various treatments are seen over 24-h period and compared between an initial dose and a dose given following 6 weeks of continuous treatment. We observed an increase in concentration of testosterone in all treatment groups after 6 weeks of treatment in the PP population. Effect of enclomiphene citrate on pharmacodynamic variables in the PP population The secondary efficacy variables were the changes in total testosterone, LH and FSH over the course of the study. At 6 weeks, subjects underwent a 24-h assessment of total testosterone and LH. Enclomiphene is particularly relevant for younger men diagnosed with secondary male hypogonadism. Enclomiphene offers a way to address the symptoms of low testosterone without this trade-off. The decision to explore enclomiphene should always be made in consultation with a specialist, like a urologist or endocrinologist. According to expert opinion, the decision to use enclomiphene must balance its known short-term benefits against these unknown long-term risks. Areas that require further study include its impact on bone density, cardiovascular health, and prostate health over the long run. A significant gap in our understanding of enclomiphene is its long-term safety. Subjects received a study medication kit, containing a 2-week supply of study medication. Blood samples were also collected to test for lipids and hormones and subjects were asked to follow a normal ad libitum diet. Transdermal testosterone was applied as per the package insert. Subjects agreed to use a condom or another form of contraception during the study. Institutional review board or independent ethics committee approvals were obtained at each centre, all patients provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki and principles of good clinical practice. Two US sites participated in the study between July and October 2011. The present study was a randomized, single-blind, phase II, four-arm study with a 6-week active dosing period. It is tempting to speculate that the effect of daily administration of an anti-oestrogen such as enclomiphene citrate results in the restoration of the normal underlying LH and FSH patern that has been lost in men with secondary hypogonadism. The effects were most likely attributable to the effects initiated through the oestrogen antagonist properties of enclomiphene citrate or its metabolite. Perhaps, the most significant observation in the present study was the restoration of normal levels and pattern of total testosterone plus normal or elevated levels of LH, unlike that seen with the exogenous testosterone treatment.
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