Enclomiphene in the Treatment of Secondary Hypogonadal Men
Obesity, or merely being overweight, is the leading cause of low testosterone in men of any age. Low testosterone does not lead to obesity (EMAS, Rastrelli 2015) but low testosterone is one of many symptoms associated with the metabolic syndrome. Recent studies have shown that weight loss not only yields improved metabolic function but also increases production of endogenous testosterone (Camacho,
Studies of hormone replacement injection therapy in obese hypogonadal men have shown a host of improved metabolic parameters including significant weight loss. When therapy is stopped, however, the metabolic symptoms, accompanied by weight gain, return (Yassin, Clinical Endocrinology 2015). Paradoxically, Rastrelli has shown once a man loses sufficient weight normal endogenous production of testosterone can be realized.
In the ongoing double blind placebo controlled proof of concept study, rigorous diet and exercise with or without enclomiphene will be evaluated to determine how quickly obese men can achieve sustainable improvements in metabolic parameters. The study will be 15 months in length and consist of three phases.
During the first six month phase, men are randomized to either enclomiphene or placebo and are provided a commercially available prepared diet along with enrollment in a trainer-based exercise program. At the end of the six month period the subjects will be assessed for changes in a variety of biochemical markers as well as anatomical markers such as waist circumference, lean body mass and BMI. Quality of life will also be assessed. Three and six month data should be available before the end of summer 2016.
During the second six month phase men will continue treatment with enclomiphene or placebo but will no longer be provided the commercial diet. Exercise will continue during this period and all parameters will be re-assessed.
In the last three months of the study the subjects will no longer receive treatment but will stay enrolled in the exercise program. This period is to determine the durability of effects due to diet and exercise alone compared to that achieved with the addition of enclomiphene. Based on previous studies of enclomiphene, during the first year of the trial, we believe that men should experience significant increases in their endogenous testosterone levels while on enclomiphene compared to placebo. Our hypothesis is that this increase in endogenous testosterone will result in improved performance during the exercise portion of the trial resulting in more rapid achievement of sustainable health goals.
The study has been submitted to the FDA's
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