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Cited by 63Hormonal and reproductive studiesHypothalamic control of reproductive hormonesSperm and Testicular Function

Effects of clomiphene citrate on male obesity-associated hypogonadism: a randomized, double-blind, placebo-controlled study

Soares, Andressa Heimbecher, Horie, Nidia Celeste, Chiang, Lucas Augusto Piccinin, Caramelli, Bruno, Matheus, Mariana Gomes, Campos, Alexandre Holthausen, Marti, Luciana Cavalheiro, Rocha, Fernanda Agostini +3 more·2018·International Journal of Obesity
DOI 10.1038/s41366-018-0105-2
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Abstract

Background Obesity causes secondary hypogonadism (HG) in men. Standard testosterone (T) replacement therapy improves metabolic parameters but leads to infertility. Objective To evaluate clomiphene citrate (CC) treatment of adult men with male obesity-associated secondary hypogonadism (MOSH). Design Single-center, randomized, double-blind, placebo-controlled trial. Participants Seventy-eight men aged 36.5 ± 7.8 years with a body mass index (BMI) > 30 kg/m 2, total testosterone (TT) ≤ 300 ng/dL, and symptoms in the ADAM questionnaire. Intervention Random allocation to receive 50 mg CC or placebo (PLB) for 12 weeks. Outcomes (1) Clinical features: ADAM and sexual behavior questionnaires; (2) hormonal profile: serum TT, free T, estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin (SHBG); (3) body composition: BMI, waist circumference, and bioelectric impedance analysis; (4) metabolic profile: blood pressure, fasting blood glucose, HbA1c, insulin, HOMA-IR, and lipid profile; (5) endothelial function: flow-mediated dilation of the brachial artery, quantitative assessment of endothelial progenitor cells and serum sICAM-1, sVCAM-1, and selectin-sE levels; (6) safety aspects: hematocrit, serum prostate-specific antigen, International Prostate Symptom Score, and self-reported adverse effects. Results There was an improvement in one sexual complaint (weaker erections; P < 0.001); increases (P < 0.001) in TT, free T, E2, LH, FSH, and SHBG; and improvements in lean mass (P < 0.001), fat-free mass (P = 0.004), and muscle mass (P < 0.001) in the CC group. CC reduced HDL (P < 0.001). No statistically significant differences were seen in endothelial function. Conclusions CC appeared to effectively improve the hormonal profile and body composition. CC may be an alternative treatment for MOSH in adult men.

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Crossref · 10.1038/s41366-018-0105-2

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  • A placebo-controlled randomized controlled trial with clomiphene citrate in 78 obese patients with functional central hypogonadism demonstrated no difference in overall ADAM questionnaire score between the 2 groups after a treatment period of only 12 weeks.

    “In contrast, a placebo-controlled randomized controlled trial (RCT) with clomiphene citrate in 78 obese patients with functional central hypogonadism demonstrated no difference in overall ADAM questionnaire score between the 2 groups after a treatment period of only 12 weeks [62].”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [62]

  • Soares et al. showed significant improvements in lean mass, muscle mass and fat-free mass in the group treated with clomiphene citrate compared to placebo.

    “Soares et al. showed significant improvements in lean mass, muscle mass and fat-free mass in the group treated with clomiphene citrate compared to placebo.”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [62]

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Authors
Soares, A. H., Horie, N. C., Chiang, L. A. P., Caramelli, B., Matheus, M. G., Campos, A. H., Marti, L. C., Rocha, F. A., Mancini, M. C., Costa, E. M. F., & Cercato, C.
Affiliations
  • Universidade de São Paulo (BR)
  • Hospital Israelita Albert Einstein (BR)
ORCID
Venue
International Journal of Obesity
Publisher
Springer Science and Business Media LLC
Published
2018-05
Volume
42
Issue
5
Pages
953-963
ISSN
  • 0307-0565 (ISSN-L)
  • 1476-5497
DOI
10.1038/s41366-018-0105-2
OpenAlex
W2804511542
Cited by
63
References
54
Citations by year
2026: 5 · 2025: 6 · 2024: 8 · 2023: 8 · 2022: 15 · 2021: 5 · 2020: 5 · 2019: 8 · 2018: 3
FWCI
4.21
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • International Journal of Obesity (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Universidade de São Paulo
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
  • Health Sciences › Medicine › Reproductive Medicine › Sperm and Testicular Function
Keywords
clomiphene citrate, secondary hypogonadism, testosterone replacement therapy, body composition, sexual function, endothelial function, insulin resistance, lipid profile, sex hormone-binding globulin, luteinizing hormone, estradiol, erectile dysfunction
MeSH terms
Adult, Clomiphene, Double-Blind Method, Estrogen Antagonists, Humans, Hypogonadism, Male, Obesity

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