Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

In this prospective open clinical study, Pubertal Replacement in Boys Study (PRIBS), boys 14-16 years with delayed puberty in terms of slow pubertal progression, were randomized to SoC treatment with TE: Testostoviron depot® 75 mg intramuscularly (i.m) / month (6 injections), or low dose TU: Nebido® 250mg i.m. / 3 months (2 injections). Our goal was to implement a study similar to clinical routine.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NU-Hospital Organization, Sweden
• Treatments: Testosterone undecanoate

Criteria

Inclusion Criteria:

• • Signed informed consent

• Two morning testosterone values (07.30-09.00) of 1-3 nmol/L and at start < 4 mmol/L ¹

• Testicular volume 4-6 mL bilaterally²

Exclusion Criteria:

• • Growth spurt

• Untreated hypothyroidism, celiac disease or steroid medication

• Training doses > 10 hours a week

• Use of anabolic steroids or other drugs