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NCT05541172
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism
trial testing Testosterone Undecanoate in Delayed Puberty in 27 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Hospital de Niños R. Gutierrez de Buenos Aires |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 27 |
| Start date | 1 March 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Argentina |
Drugs / interventions tested
- Testosterone Undecanoate (TESTOSTERONE UNDECANOATE) — full drug profile →
Conditions studied
- Delayed Puberty — all drugs for Delayed Puberty →
- Male Hypogonadism — all drugs for Male Hypogonadism →
Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Who can join
Adults 12 to 18, male only, with Delayed Puberty or Male Hypogonadism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The absence of clinical signs of pubertal maturation, i.e. pubertal delay, is a relatively frequent reason for consultation in boys. In cases where it is necessary, the treatment to be established is the administration of testosterone with the aim of provoking the development of secondary sexual characteristics and optimizing growth. Currently, the most commonly used treatment is empirical, with im testosterone enanthate at increasing doses (from 50 mg every 4 weeks up to 250 mg every 4 weeks) over a period of 2 to 3 years. The pharmacokinetic profile has not been described to see if it mimics the physiological progressive increase in testosterone levels occurring during normal puberty. In adults, testosterone enanthate shows supraphysiological serum testosterone the first week after, with a progressive drop to subphysiological levels in the fourth week. Testosterone undecanoate is used in adults at a dose of 1000 mg im every 12 weeks, as equivalent to testosterone enanthate 250 mg every 4 weeks.Serum levels of testosterone show a profile within physiological ranges. Testosterone undecanoate im has not been tested in adolescents. Hypothesis: The hypothesis of this work is that the initial administration of 1 ml (\~250 mg) of testosterone undecanoate (1000 mg/4 ml) via im every 12 weeks for 6 months, with a progressive increase of 1 ml (\~250 mg) every 6 months until reaching 4 ml (1000 mg) per dose is safe and effective in causing normal progression of secondary sex characteristics and growth spurt in boys with pubertal delay. The primary specific objectives are to determine, in boys with pubertal delay: (a) if a treatment regimen of testosterone undecanoate (1000 mg/4 ml), with an initial dose of 250 mg every 12 weeks and subsequent increase up to 1000 mg every 12 weeks over 2 years (increasing 250 mg every 6 months) induces a progression in the development of secondary sexual characteristics and growth spurt commensurate with those of normal pubertal development, and (b) the safety of the administration of increasing doses of im testosterone undecanoate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05541172
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05541172 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Niños R. Gutierrez de Buenos Aires
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05541172.
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