WHO ICTRP trial
Hormone treatment of boys with absent or delayed puberty
EUCTR2012-002337-11-SE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-002337-11-SE |
|---|---|
| Public title | Hormone treatment of boys with absent or delayed puberty |
| Scientific title | A multicenter and randomised clinical study on pubertal replacement therapy in boys - Treatment of boys with absent or delayed puberty with rhFSH and two different formulations of testosterone in low dose: Testoviron Depot® and Nebido® - Pubertal replacement therapy in boys |
| Primary sponsor | Västra Götalandsregionen (VGR) |
| Secondary sponsors | Sahlgrenska Academy-Gothenburg University Institute |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Sweden |
| Conditions | Delayed or absence of puberty MedDRA version: 15.1 Level: LLT Classification code 10012180 Term: Delay in sexual development and puberty, not elsewhere classified System Organ Class: 100000004860 ;Therapeutic area: Body processes [G]… |
| Interventions | Trade Name: Testoviron Depot® Soulution for injection i.m. 250mg/mL Pharmaceutical Form: Solution for injection INN or Proposed INN: TESTOSTERONE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50-75… |
| Registration date | Jun 18, 2012 |
| Target size | 70 |
| Secondary IDs | Pub-01 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: