Testosterone treatment for boys with delayed puberty or hypogonadism
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism
This study tests if a new type of testosterone treatment can help boys aged 12 to 18 with delayed puberty or low testosterone develop normally and grow better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 27 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | Male |
| Sponsor | Hospital de Niños R. Gutierrez de Buenos Aires Academic / other |
| Locations | 1 site (Buenos Aires, Distrito Federal) |
| Trial ID | NCT05541172 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the use of testosterone undecanoate replacement therapy in boys aged 12 to 18 years who exhibit delayed puberty or have confirmed hypogonadism. The aim is to assess the effectiveness of this treatment in promoting the development of secondary sexual characteristics and optimizing growth. Unlike the commonly used testosterone enanthate, which has a fluctuating pharmacokinetic profile, testosterone undecanoate is administered less frequently and may provide a more stable testosterone level. The study will involve monitoring the boys' responses to the treatment over time.
Who should consider this trial
Good fit: Ideal candidates are males aged 12 to 18 years with no signs of pubertal development or those aged 13 to 18 years with a confirmed diagnosis of anorchia or hypogonadism.
Not a fit: Patients with a bone age of less than 11 years or those allergic to the medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and stable approach to managing delayed puberty and hypogonadism in boys.
How similar studies have performed: While testosterone undecanoate is commonly used in adults, its application in this specific pediatric population is less established, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males between 13 and 18 years old without signs of pubertal development, or between 12 and 18 years old with a confirmed diagnosis of anorchia or hypogonadism. * Normal male configuration of the external genitalia for Tanner G1 stage, with or without palpable testicles, as defined in 4.5. * As appropriate, assent/consent of the patient and their parents or guardians. Exclusion Criteria: * Bone age \< 11 years. * Allergy to the medication of the study.
Where this trial is running
Buenos Aires, Distrito Federal
- Rodolfo Rey — Buenos Aires, Distrito Federal, Argentina (Recruiting)
Study contacts
- Study coordinator: Rodolfo Rey, MD, PhD
- Email: rodolforey@cedie.org.ar
- Phone: 54-11-49635931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.