Clomiphene's Efficacy in Treating Male Hypogonadism: A Retrospective Analysis of Testosterone Levels, Symptom Improvement, and Safety Profile

madman

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* Our study suggests the efficacy of clomiphene for treatment of male patients presenting with hypogonadal symptoms as measured by both serum testosterone levels and reported symptom improvement. Clomiphene use alone or in combination with TRT was associated with increased estradiol levels in this patient cohort. The data supports the potential benefits of clomiphene to treat hypogonadal symptoms in select patients.




Clomiphene’s Efficacy in Treating Male Hypogonadism: A Retrospective Analysis of Testosterone Levels, Symptom Improvement, and Safety Profile


Boyne, A1; Fleming, B1; La, T1; Desai, S1; Saffati, G1; Orozco Rendon , D1; Khera, M1

1 - Baylor College of Medicine


Introduction:

Hypogonadism in men can significantly impact quality of life. Clomiphene is a selective estrogen receptor modulator used to induce ovulation by increasing luteinizing (LH) and follicle-stimulating hormone (FSH) levels. While testosterone replacement therapy (TRT) is a common treatment, clomiphene citrate has emerged as an alternative approach. However, there is a paucity of data regarding its clinical effectiveness.


Objective:

We sought to determine the efficacy of clomiphene in improving testosterone levels and hypogonadal symptoms in patients at our institution.


Methods:

Patients treated with clomiphene were for hypogonadal symptoms were retrospectively identified from a single institution database. Total serum testosterone and estradiol were compared before and after treatment with clomiphene using two-tailed student’s t-test for paired analyses and Welches t-test for unpaired analyses. Odds ratios (OR)for adverse events were calculated using the Fisher-exact test.


Results:

76 men (mean age 37.5 years) presenting with hypogonadism (28.9%), infertility (32.9%), or other symptoms of low energy or libido (38.2%) were prescribed clomiphene by sexual medicine specialists at our institution. Mean total testosterone measured at the first visit and last follow up were 320.93 ± 247.38 ng/dL and 568.30 ± 438.69 ng/dL respectively (p < 0.001). Patients noted improvement of ED (75.9%), libido (74.6%), energy (82%), weight (60.0%), muscle mass (67.4%), and depressive symptoms (31.3%) following administration of clomiphene. Mean estradiol measured at the first visit and last follow up were 27.31 ± 15.11 pg/mL and 34.51 ± 22.11 pg/dL respectively (p = 0.02). Men undergoing treatment with clomiphene alone (n = 42, 55.3%) had significantly lower rates of polycythemia than those undergoing treatment with testosterone replacement therapy (TRT) and clomiphene (n=34, 44.7%) (OR 0.096 (95% confidence interval: 0.002 - 0.813)).


Conclusions:

Our study suggests the efficacy of clomiphene for treatment of male patients presenting with hypogonadal symptoms as measured by both serum testosterone levels and reported symptom improvement. Clomiphene use alone or in combination with TRT was associated with increased estradiol levels in this patient cohort. The data supports the potential benefits of clomiphene to treat hypogonadal symptoms in select patients.


Disclosure:

Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast, Halozyme Investor: Sprout




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Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

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Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

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The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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