I am Principal Investigator for a case study on the use of Clomiphene in men. Clomiphene is a generic drug approved by the FDA for use in women to help them ovulate. In men, Clomiphene has an off-label use to stimulate the endogenous production of testosterone by reducing the negative feedback effect of estrogen. I would be interested in communicating with doctors and physicians who have male patients in need of Clomiphene. Alternatively, I would be interested in communicating with prospective male patients interested in participating in a clinical study on the use of Clomiphene for hormone replacement therapy. For more information, please contact me at email mike@@michaelguth.com [use only one @ symbol].
Michael A. S. Guth, Ph.D., J.D.
http://www.michaelguth.com/?p=351
Here is an abstract of a prior study similar to, but at a higher dose, than my clinical study.
Fertil Steril. 2006 Nov;86(5):1513.e5-9.
Complete reversal of adult-onset isolated hypogonadotropic hypogonadism with clomiphene citrate.
Ioannidou-Kadis S, Wright PJ, Neely RD, Quinton R. Department of Endocrinology, Royal Victoria Infirmary and University of Newcastle-upon-Tyne, Newcastle-upon-Tyne, United Kingdom.
OBJECTIVE: Inhibition of pituitary gonadotropin secretion in men by T is principally mediated by aromatization to estrogen (E), which inhibits hypothalamic secretion of GnRH. We hypothesized that adult-onset isolated hypogonadotropic hypogonadism (IHH) might result from an altered central set-point for E-mediated negative feedback. DESIGN AND SETTING: Longitudinal clinical investigation unit-based evaluation of the clinical and biochemical response to E-receptor blockade. PATIENT(S): A 31-year-old man presenting with an 18-month history of sexual dysfunction resulting from severe adult-onset IHH (LH 1.7 U/L, FSH 2.0 U/L, T 3.5 nmol/L). INTERVENTION(S): Initial therapy with 50 mg of clomiphene citrate (CC) three times a day for 7 days, with overnight LH pulse profiling and 9 am T levels evaluated at baseline and on completion. A 2-month washout period, followed by low-dose maintenance therapy (25-50 mg/d) for 4 months. MAIN OUTCOME MEASURE(S): Baseline and stimulated T levels and LH pulsatility; effect on sexual function. RESULT(S): Clomiphene therapy resulted in complete normalization of pulsatile gonadotropin secretion, serum T level, and sexual function. CONCLUSION(S): Isolated hypogonadotropic hypogonadism may result from an acquired defect of enhanced hypothalamic sensitivity to E-mediated negative feedback. Whereas direct T replacement therapy can further suppress endogenous gonadotropin secretion, treating IHH men with gonadotropins can stimulate endogenous T secretion and enhance fertility potential. On theoretical grounds, reversal of gonadotropin deficiency with CC might be expected to have a similar biological effect.



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