Trial design
CELIAC DISEASE, MASCULINIZATION, DELAYED PUBERTY, SECONDARY, BLOOD, HYPOTHYROIDISM
In this prospective open-label clinical study, the Pubertal Replacement in Boys Study (PRIBS), boys 14–16 years old with delayed puberty in terms of slow pubertal progression were randomized to SoC treatment with TE (Testoviron DepotThe PRIBS patients were seen by one of the three study doctors (the present authors). Three study nurses took all the blood samples for testing and administered the injections. Blood was sampled before 09:00 a.m. All nine PRIBS visits took place at the study sites. The TV was determined using a Prader orchidometer.The primary objective of this study was to evaluate the effect of TE and TU on pubertal development in boys with delayed puberty or slow pubertal progression. The secondary objectives concerned hormone levels, growth, signs of masculinization, and tolerability.Since a TV ≥ 8 ml represents mid-puberty (The aim for the TU patients was to have the same morning testosterone levels (4–9 nmol/L) after the first injection as those of boys in transition from early to mid-puberty (In Swedish Growth Charts, there are prepubertal growth lines between 11.5 and 15 years. The definition of a start growth spurt in the present study was an increase of 0.3 height SDS (The signed informed consent;two morning testosterone values (07:30–09:00 a.m.) of <3 nmol/L and at the study start of <4 mmol/L;TV of 4–6 ml bilaterally (patients with a TV of 2–3 ml could be included if they had pubertal morning testosterone values of 1–3 nmol/L and a pubertal GNRH test); andbone age ≥11 years (since there was a change in bone age determination methodology during the study period, this inclusion criterion was not used).The growth spurt;untreated hypothyroidism, celiac disease, or steroid medication;athletic training >10 h/week; anduse of anabolic steroids or other drugs.