Cited by 128Male Breast Health StudiesEstrogen and related hormone effectsHypothalamic control of reproductive hormones

Safety and Efficacy of Anastrozole for the Treatment of Pubertal Gynecomastia: A Randomized, Double-Blind, Placebo-Controlled Trial

Plourde, Paul V., Reiter, Edward O., Jou, Hann-Chang, Desrochers, Paul E., Rubin, Stephen D., Bercu, Barry B., Diamond, Frank B., Backeljauw, Philippe F. +1 more·2004·The Journal of Clinical Endocrinology & Metabolism

Abstract

Pubertal gynecomastia is thought to result from transient imbalances between estrogen and androgen concentrations. Anastrozole (ARIMIDEX), a potent and selective aromatase inhibitor, decreases estrogen and increases testosterone concentrations in pubertal boys. The safety and efficacy of anastrozole for the treatment of pubertal gynecomastia were evaluated. In a randomized, double-blind, placebo-controlled study of 80 boys, aged 11-18 yr, with pubertal gynecomastia that had not reduced over a 3-month interval, subjects received either anastrozole (1 mg) or placebo once daily for 6 months. A response was defined as a 50% or greater reduction in the calculated volume of both breasts combined using ultrasonography measurements. A comparison of response rates was performed using logistic regression analysis. Secondary end points included changes in serum hormone concentrations. The percentage of patients with a response was 38.5% for the anastrozole group and 31.4% for the placebo group (odds ratio, 1.513; 95% confidence interval, 0.496-4.844; P = 0.47). At 6 months, the median percent change in the testosterone/estradiol ratio was 166% for the anastrozole group and 39% for the placebo group. Anastrozole treatment was well tolerated. In patients with pubertal gynecomastia, no significant difference in the percentage of patients with a 50% or greater reduction in total breast volume, as calculated from ultrasonography measurements, was demonstrated between the anastrozole and placebo groups.

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Registry

Crossref · 10.1210/jc.2004-0082

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47 of 47 references verified0 citation errors · 0 not checkable

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  • Aromatase inhibitors effectively delay epiphysial maturation in boys.

    “Aromatase inhibitors effectively delay epiphysial maturation in boys and improve testosterone levels in adult men”

    From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [55]

  • This approach proved successful in rare conditions such as the aromatase-excess syndrome and high estrogen levels due to Sertoli cell tumors in boys with Peutz-Jeghers syndrome.

    “This approach proved successful in rare conditions such as the aromatase-excess syndrome [25] and high estrogen levels due to Sertoli cell tumors in boys with Peutz-Jeghers syndrome [55].”

    From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [55]

  • Estrogens are essential for epiphysial maturation in boys.

    “Estrogens are essential for epiphysial maturation in boys.”

    From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [55]

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Authors
Plourde, P. V., Reiter, E. O., Jou, H.-C., Desrochers, P. E., Rubin, S. D., Bercu, B. B., Diamond, F. B., Backeljauw, P. F., & Study, M. O. T. A. G.
Affiliations
  • AstraZeneca (United States) (US)
  • Baystate Medical Center (US)
  • University of South Florida (US)
  • Cincinnati Children's Hospital Medical Center (US)
Corresponding author
Plourde, Paul V.
Venue
The Journal of Clinical Endocrinology & Metabolism
Published
2004-09-01
Volume
89
Issue
9
Pages
4428-4433
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
OpenAlex
W2117785194
Cited by
128
References
48
Citations by year
2026: 4 · 2025: 1 · 2024: 8 · 2023: 5 · 2022: 5 · 2021: 6 · 2020: 4 · 2019: 2 · 2018: 4 · 2017: 7 · 2016: 5 · 2015: 6 · 2014: 5 · 2013: 3 · 2012: 4
FWCI
8.11
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Male Breast Health Studies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
  • Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
Keywords
pubertal gynecomastia, anastrozole, aromatase inhibitors, testosterone/estradiol ratio, adolescent boys, drug safety and efficacy
MeSH terms
Anastrozole, Adolescent, Child, Double-Blind Method, Enzyme Inhibitors, Estradiol, Gynecomastia, Humans, Male, Nitriles, Testosterone, Triazoles

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