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Context: The use of testosterone enanthate (TE), 50-75 mg intramuscularly (i.m.)/month, for the treatment of boys with delayed puberty or slow progression to induce puberty is the standard of care (SoC) in Sweden. This treatment is empirical and has not been scientifically evaluated. Replacement therapy in hypogonadal boys/young men in Sweden after induction is mainly performed with testosterone undecanoate (TU), 1,000 mg/3 months. TE is only available on license. TE was deregistered in Sweden in 2006. Therefore, this study was initiated to compare the two products. Objective: To clinically evaluate pubertal progression with six injections of TE, 75 mg i.m./month (1/3-1/5 of adult dose), compared with two injections of TU, 250 mg i.m./3 months (1/4 of adult dose). Trial design: In the Pubertal Replacement in Boys Study (PRIBS), boys aged 14-16 years in West Sweden with pubertal delay were randomized in a parallel study to TE or TU for pubertal progression. Inclusion criteria were morning testosterone levels of 0.5-3 nmol/L and testicular volume =6 ml. Between June 2014 and Nov 2019, 27 boys were included. Methods: The primary outcome was testicular enlargement =8 ml after 12 months. TU treatment was considered clinically similar if the number of boys with testicular enlargement =8ml was 80%-125% of the number of boys with TE. Fisher's exact chi-square test was used for this analysis. Results: Both treatments were well tolerated. Twelve of 14 (86%) TU-treated boys reached the primary outcome and 12/12 in the TE group. Fisher's exact chisquare testing indicated a one-sided p-value of 0.28 (the two-sided p-value was 0.483). The TU treatment was considered not clinically different from SoC. A post-hoc study showed 25% power. Therefore, no evidence-based conclusion can be drawn from the results even if the clinical data support a similar effect of the treatments. Conclusion: The present small-scale study supports that both TE and TU had similar effects in terms of pubertal progression. [ABSTRACT FROM AUTHOR]

Objective: The aim of this work was to investigate the prevalence of premature thelarche (PT) in 18-month-old girls, and the incidence of clinically evaluated PT for girls aged 18–36 months. Methods: In the prevalence substudy, a prospective population-based cohort of 3,140 girls born at Northern Älvsborg county hospital (NÄL) in Trollhättan, Sweden, was followed for 2 years. Girls with breast development at the 18-month health check were referred to one pediatric center in NÄL for evaluation. All girls with PT were included and followed for clinical outcome and 17β-estradiol. The prospective incidence substudy covered 8 years in a 10-year period and included all girls aged 18–36 months born at NÄL who were clinically evaluated for PT. Results: The prevalence of PT at 18 months in our cohort was 1.6/1,000. The 5 girls with PT no longer showed symptoms at the follow-up 3–6 months later. The incidence was 1.1/1,000 for girls aged 18–36 months and 1.0/1,000 for girls aged 18–30 months who were clinically evaluated for their PT. Conclusion: This is the first prospective population-based study of PT and it shows a prevalence of PT at age 18 months of 1.6/1,000. The incidence of clinically evaluated PT was 1.1/1,000. Our result is in line with other studies reporting the incidence of PT from medical records (0.4–40/1,000). The outcome of PT in our study, as in the other studies, is that the great majority of girls show only benign symptoms. [ABSTRACT FROM AUTHOR]

Background: Early onset of breast development in a young girl is usually a benign and isolated prepubertal condition, i.e., premature thelarche (PT), but can sometimes be progressive and the first sign of pubertal precocity (PP). Serum 17β-estradiol (17β-E2) level is a possible marker to differentiate between benign and pathological forms of breast development. We defined an upper serum 17β-E2 level for benign, “classic” PT for girls aged 9–48 months. Methods: Serum 17β-E2 was analysed with a highly sensitive extraction radioimmunoassay (RIA). Gonadotropins, Tanner breast stage, growth, other investigations, and clinical outcome were assessed in 125 girls with breast development, in a population-based study in West Sweden. Results: A total of 125 of 128 girls had a benign form of breast development with a mean serum 17β-E2 level of 15.2 pmol/L and a mean + 2 SD of 31 pmol/L, which was regarded as the upper limit for benign PT; 3 girls with PP had 17β-E2 levels above 70 pmol/L. Conclusion: This is the first study to define an upper serum 17β-E2 level associated with benign PT. Girls aged 9–48 months with PT and Tanner breast stage 2 have 17β-E2 levels below 32 pmol/L using extraction RIA. LH below the detection limit (0.1 IU/L) and measurable FSH support benign PT. [ABSTRACT FROM AUTHOR]