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Safety and Efficacy of Anastrozole for the Treatment of Pubertal Gynecomastia: A Randomized, Double-Blind, Placebo-Controlled Trial
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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“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]
In the citing paper
“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]
In the citing paper
“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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133 Borstzwelling bij mannen/gynaecomastie
de Jongh, T. O. H. (2016) · Bohn Stafleu van Loghum eBooks · doi:10.1007/978-90-368-1386-0_133
Metadata
- 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
- Publisher
- The Endocrine Society
- 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 › Oncology › Male Breast Health Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › 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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