Human Chorionic Gonadotropin monotherapy for the treatment of hypogonadal symptoms in men with total testosterone > 300 ng/dL

Abstract

Purpose The 2018 American Urological Association guidelines on the Evaluation and Management of Testosterone Deficiency recommended that 300 ng/dL be used as the threshold for prescribing testosterone replacement therapy (TRT). However, it is not uncommon for men to present with signs and symptoms of testosterone deficiency, despite having testosterone levels greater than 300 ng/dL. There exists scant literature regarding the use of hCG monotherapy for the treatment of hypogonadism in men not interested in fertility. We sought to evaluate serum testosterone response and duration of therapy of hCG monotherapy for men with symptoms of hypogonadism, but total testosterone levels > 300 ng/dL.Materials and Methods We performed a multi-institutional retrospective case series of men receiving hCG monotherapy for symptomatic hypogonadism. We evaluated patient age, treatment indication, hCG dosage, past medical history, physical exam findings and serum testosterone and gonadotropins before and after therapy. Descriptive analysis was performed and Mann Whitney U Test was utilized for statistical analysis.Results Of the 20 men included in the study, treatment indications included low libido (45%), lack of energy (50%), and erectile dysfunction (45%). Mean testosterone improved by 49.9% from a baseline of 362 ng/dL (SD 158) to 519.8 ng/dL (SD 265.6), (p=0.006). Median duration of therapy was 8 months (SD 5 months). Fifty percent of patients reported symptom improvement.Conclusions Treatment of hypogonadal symptoms with hCG for men who have a baseline testosterone level > 300 ng/dL appears to be safe and efficacious with no adverse events.

The availability of gonadotropin therapy from FDA-approved pharmacies for men with hypogonadism and infertility

“…For hCG therapy, regimens have been utilized such as dosing regimens including 2000 IU human chorionic gonadotropin (hCG) weekly, with patients receiving alternating biweekly and triweekly injections. 14 Like FSH and LH, cost varies substantially, with 1 study reporting a monthly cost of$359 while pharmacies within our study reported monthly costs of less than$75 USD per month. 15 …”

“…Delivery and specific drug formulations become more complicated in FSH, LH, and hCG therapy. 10 , 14 With the exception of 1 recombinant FSH (rFSH) formulation, FSH and LH are given as injections, frequently every other day, which may be challenging for some patients to administer and are less favorable as delivery mechanisms than oral medications. 10 In FSH and LH therapy, there are basic distinctions between urinary-derived, highly purified (HP) FSH/HP LH, and rFSH and LH exists.…”

Efficacy and Safety of Human Chorionic Gonadotropin Monotherapy for Men With Hypogonadal Symptoms and Normal Testosterone

“…The use of hCG has historically been recommended for men with TD interested in maintaining fertility or recovering sperm production in men previously on exogenous testosterone [ 5 , 10 , 11 ]. Several studies support hCG therapy to recover spermatogenesis after testosterone use but do not report the effect of hCG on symptoms or side effects [ 11 ].…”

“…The American Urological Association (AUA) recommends using hCG for men with TD and fertility concerns, as it can maintain sperm production, while exogenous testosterone can act as a contraceptive. There is limited research on the efficacy and safety of hCG monotherapy, particularly in men who fail to meet the biochemical criteria for conventional TRT [ 5 ]. As a result, we sought to evaluate the response of patients to hCG monotherapy.…”

Evaluation of a serum 17-hydroxyprogesterone as predictor of semen parameter(s) improvement in men undergoing medical treatment for infertility

“…Since testosterone replacement therapy for low testosterone has the potential to inhibit spermatogenesis 21 , studies have described the use of off-label drugs for the treatment of these men. 13,14,[22][23][24][25] Based on the hypothesis that spermatogenesis disruption is caused by low levels of intratesticular testosterone, 5,16,26 we analyzed the outcomes of men treated with off-label medications that knowingly increase ITT, comparing baseline and follow-up semen parameter [s] to serum levels of 17-OHP (ITT serum biomarker) and T. We discovered that men with low 17-OHP are better responders to medical treatment and, therefore, they are likely the best candidates for medical therapy.…”