Bicalutamide plus Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotoxicosis: A Phase II, Open-Label Pilot Study (BATT)

Reiter, Edward O.; Mauras, Nelly; McCormick, Ken; Kulshreshtha, Bindu; Amrhein, James; De Luca, Francesco; O'Brien, Sandra; Armstrong, Jon; Melezinkova, Helena

doi:10.1515/jpem.2010.161

Cited by 54Hypothalamic control of reproductive hormonesSexual Differentiation and DisordersHormonal and reproductive studies

Bicalutamide plus Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotoxicosis: A Phase II, Open-Label Pilot Study (BATT)

Reiter, Edward O., Mauras, Nelly, McCormick, Ken, Kulshreshtha, Bindu, Amrhein, James, De Luca, Francesco, O'Brien, Sandra, Armstrong, Jon +1 more·2010·Journal of Pediatric Endocrinology and Metabolism

DOI 10.1515/jpem.2010.161

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Abstract

OBJECTIVE: To evaluate the efficacy, tolerability, and pharmacokinetics of bicalutamide plus anastrozole in young males with testotoxicosis. METHODS: This was a multicenter, open-label, single-arm, 12-month, Phase II pilot trial in 14 males (2-9 years) with testotoxicosis treated with bicalutamide (12.5, 25, 50, or 100 mg) and anastrozole (0.5 or 1 mg) daily. The primary outcome was change in growth rate. RESULTS: At 1 year, the mean (standard deviation) change from baseline in growth rate was -1.6 (+/- 5.1) cm/year and -0.1 (+/- 1.8) SD units, and in bone maturation was -2.3 (+/- 0.5) years. The bone age/chronological age ratio was reduced from 2.1 (+/- 0.6) at baseline to 1.0 (+/- 0.4) (p = 0.00013). Steady-state trough R-bicalutamide and anastrozole concentrations were attained by Day 21 and 8, respectively. Gynecomastia (42.9%) and breast tenderness (12.5%) were the most common treatment-related adverse events. CONCLUSIONS: Treatment of testotoxicosis with bicalutamide plus anastrozole resulted in slower growth rate.

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Uncontrolled studies using anastrozole, testolactone or letrozole have shown some evidence for a positive effect on sperm concentration and motility.
“Uncontrolled studies using anastrozole, testolactone or letrozole have shown some evidence for a positive effect on sperm concentration and motility [49-51].”
From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [49]

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Treatment of Familial Male-limited Precocious Puberty (Testotoxicosis) with Anastrozole and Bicalutamide in a Boy with a Novel Mutation in the Luteinizing Hormone Receptor
Mitre, N., & Lteif, A. (2009) · Journal of Pediatric Endocrinology and Metabolism · doi:10.1515/jpem.2009.22.12.1163 · Cited by 12 · see citing works
Testotoxicosis: current viewpoint.
Reiter, E. O., & Norjavaara, E. (2005) · PubMed · Cited by 30 · see citing works
Self-citation
Central precocious puberty in a case of late-diagnosed familial testotoxicosis and long-term treatment monitoring
Kör, Y. (2018) · HORMONES · doi:10.1007/s42000-018-0029-1 · Cited by 5 · see citing works
Treatment of familial male-limited precocious puberty with bicalutamide and anastrozole
Kreher, N. C., Pescovitz, O. H., Delameter, P., Tiulpakov, A., & Hochberg, Z. (2006) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2006.04.027 · Cited by 59 · see citing works

Authors: Reiter, E. O., Mauras, N., McCormick, K., Kulshreshtha, B., Amrhein, J., De Luca, F., O'Brien, S., Armstrong, J., & Melezinkova, H.
Affiliations: Tufts University (US)
Nemours Children's Clinic (US)
University of Alabama at Birmingham (US)
All India Institute of Medical Sciences (IN)
AstraZeneca (United Kingdom) (GB)
ORCID: Reiter, Edward O.
Mauras, Nelly
Kulshreshtha, Bindu
Armstrong, Jon
Venue: Journal of Pediatric Endocrinology and Metabolism
Publisher: Walter de Gruyter GmbH
Published: 2010-01
Volume: 23
Issue: 10
Pages: 999-1009
ISSN: 0334-018X (ISSN-L)
2191-0251
DOI: 10.1515/jpem.2010.161
OpenAlex: W2091555378
Cited by: 54
References: 28
Citations by year: 2025: 1 · 2024: 6 · 2023: 5 · 2022: 6 · 2021: 3 · 2020: 2 · 2019: 5 · 2018: 6 · 2017: 2 · 2015: 8 · 2013: 3
FWCI: 3.41
Type: journal article
Language: en
Open access: closed
Locations: Journal of Pediatric Endocrinology and Metabolism (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Keywords: testotoxicosis, gonadotropin-independent precocious puberty, bicalutamide, anastrozole, androgen deprivation therapy, growth rate, skeletal maturation, bone age, pharmacokinetics, gynecomastia, pediatric boys
MeSH terms: Anastrozole, Anilides, Bone Development, Child, Child, Preschool, Drug Therapy, Combination, Gonadotropins, Growth, Humans, Male, Nitriles, Pilot Projects, Puberty, Precocious, Tosyl Compounds, Triazoles

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Bicalutamide plus Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotoxicosis: A Phase II, Open-Label Pilot Study (BATT)

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