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Cited by 136Hormonal and reproductive studiesAdrenal Hormones and DisordersHypothalamic control of reproductive hormones

Clomiphene citrate is safe and effective for long‐term management of hypogonadism

Moskovic, Daniel J., Katz, Darren J., Akhavan, Ardavan, Park, Kelly, Mulhall, John P.·2012·BJU International
DOI 10.1111/j.1464-410x.2012.10968.x
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Abstract

Study Type – Therapy (population cohort) Level of Evidence 2a What's known on the subject? and What does the study add? Clomiphene citrate (CC) has previously been documented to be efficacious in the treatment of hypogonadism. However little is known about the long term efficacy and safety of CC. Our study demonstrates that CC is efficacious after 3 years of therapy. Testosterone levels and bone mineral density measurement improved significantly and were sustained over this prolonged period. Subjective improvements were also demonstrated. No adverse events were reported. OBJECTIVE: To assess the efficacy and safety of long‐term clomiphene citrate (CC) therapy in symptomatic patients with hypogonadism (HG). PATIENTS AND METHODS: Serum T, oestradiol and luteinizing hormone (LH) were measured in patients who were treated with CC for over 12 months. Additionally, bone densitometry (BD) results were collected for all patients. Demographic, comorbidity, treatment and Androgen Deficiency in Aging Men (ADAM) score data were also recorded. Comparison was made between baseline and post‐treatment variables, and multivariable analysis was conducted to define predictors of successful response to CC. The main outcome measures were predictors of response and long‐term results with long‐term CC therapy in hypogonadal patients. RESULTS: The 46 patients (mean age 44 years) had baseline serum testosterone (T) levels of 228 ng/dL. Follow‐up T levels were 612 ng/dL at 1 year, 562 ng/dL at 2 years, and 582 ng/dL at 3 years ( P < 0.001). Mean femoral neck and lumbar spine BD scores improved significantly. ADAM scores (and responses) fell from a baseline of 7 to a nadir of 3 after 1 year. No adverse events were reported by any patients. CONCLUSIONS: Clomiphene citrate is an effective long‐term therapy for HG in appropriate patients. The drug raises T levels substantially in addition to improving other manifestations of HG such as osteopenia/osteoporosis and ADAM symptoms.

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Crossref · 10.1111/j.1464-410x.2012.10968.x

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  • In 29 men with baseline total testosterone 228±48 ng/dL treated with CC for >3 years, testosterone improved to a mean of 582±227 ng/dL, with significant improvements in ADAM questionnaire response and mean BMI.

    “Moskovic et al. reported on 29 men with a baseline total testosterone level of 228±48 ng/dL treated for >3 years with CC. They demonstrated improvements in testosterone to a mean of 582±227 ng/dL (P<0.001), as well as significant improvements in ADAM questionnaire response (P=0.01) and mean BMI (P<0.05) (50).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [50]

  • Multiple studies have shown that clomiphene citrate effectively raises testosterone to eugonadal levels in men with testosterone deficiency.

    “CC has long been used as a treatment to restore testosterone levels and promote or preserve spermatogenesis in men with testosterone deficiency desiring to preserve fertility, and multiple studies have shown that CC effectively raises testosterone to eugonadal levels (50-56).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [50]

  • CC is well-tolerated; rare side effects include headaches, visual changes, and gynecomastia.

    “CC is well-tolerated. Rare side effects include headaches, visual changes, and gynecomastia (50).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [50]

  • One study in 46 symptomatic hypogonadal patients reported a significant increase in bone mineral density during treatment with clomiphene citrate.

    “One study in 46 symptomatic hypogonadal patients reported a significant increase in bone mineral density during treatment with clomiphene citrate [64].”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [64]

  • The effect of tamoxifen on bone mineral density is unclear.

    “In contrast, the effect of tamoxifen on bone mineral density is unclear [64].”

    From Treatment of Men with Central Hypogonadism: Alternatives for Testosterone Replacement Therapy (2020) · cites this paper as [64]

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Authors
Moskovic, D. J., Katz, D. J., Akhavan, A., Park, K., & Mulhall, J. P.
Affiliations
Memorial Sloan Kettering Cancer Center (US)
Corresponding author
Mulhall, John P.
ORCID
Venue
BJU International
Publisher
Wiley
Published
2012-03-28
Volume
110
Issue
10
Pages
1524-1528
ISSN
  • 1464-4096 (ISSN-L)
  • 1464-410X
DOI
10.1111/j.1464-410x.2012.10968.x
OpenAlex
W1604074789
Cited by
136
References
8
Citations by year
2026: 4 · 2025: 5 · 2024: 5 · 2023: 7 · 2022: 14 · 2021: 8 · 2020: 9 · 2019: 12 · 2018: 9 · 2017: 12 · 2016: 19 · 2015: 9 · 2014: 16 · 2013: 4 · 2012: 3
FWCI
8.17
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • British Journal of Urology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
Keywords
clomiphene citrate, hypogonadism, testosterone levels, bone mineral density, osteoporosis, osteopenia, luteinizing hormone, estradiol, predictors of treatment response, drug safety
MeSH terms
Adult, Clomiphene, Estradiol, Estrogen Antagonists, Humans, Hypogonadism, Luteinizing Hormone, Male, Middle Aged, Testosterone, Bone Density, Selective Estrogen Receptor Modulators

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