Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism

NCT05541172 | Recruiting DMC

• 1 other identifier: CEI 21-07
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Puberty; Male Hypogonadism

Outcome Measures

Primary Outcomes (2)

• Progression in the development of secondary sexual characteristics

  Progression of pubertal stages will be considered as in line with normal maturation if the clinical evaluation detects Tanner G2 or G3 and pubic hair (PH)2 or PH3 at the end of stage 1 (visit 8), G3 or G4 and PH3 or PH4 at the end of stage 2 (visit 14), G3 to G5 and PH3 to PH5 at the end of stage 3 (visit 20 ), and G4 or G5 and PH4 to PH6 at the end of stage 4 (visit 26). The proportion of patients with progression as hypothesized will be calculated. The therapeutic regimen shall be considered satisfactory if this proportion is ≥80%

  2 years

• Progression in the speed of growth

  Height velocity calculated as Δ stature (cm)/Δ time (months). Progression will be considered as in line with normal growth if the clinical evaluation detects a height velocity of 6 to 10 cm/year at the end of stage 2 (visit 14) and 8 to 14 cm/year at the end of stage 4 (visit 26). The proportion of patients with progression as hypothesized will be calculated. The therapeutic regimen shall be considered satisfactory if this proportion is ≥80%.

  2 years

Secondary Outcomes (1)

• Testosterone concentration in serum

  2 years

Other Outcomes (1)

• Adverse events

  2 years

Interventions

Testosterone Undecanoate DRUG

Testosterone undecanoate (1000 mg/4 ml) will be administered at a dose of 1 ml every 12 weeks for 6 months, 2 ml every 12 weeks for 6 months, 3 ml every 12 weeks for 6 months and 4 ml every 12 weeks for 6 months.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: male
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population includes boys diagnosed with anorchia, hypogonadism, or CDGP requiring testosterone treatment. All eligible patients who present consecutively until the sample size is completed will be invited to participate.

You may qualify if:

• 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.

You may not qualify if:

• Bone age \< 11 years.
• Allergy to the medication of the study.

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead
• National Agency for Scientific and Technological Promotion, Argentina: collaborator

Study Sites (1)

Rodolfo Rey

Buenos Aires, Distrito Federal, 1425, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Puberty, Delayed; Eunuchism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Study Officials

• Rodolfo Rey

  Hospital de Niños R. Gutierrez

  STUDY DIRECTOR

Central Study Contacts

Rodolfo Rey, MD, PhD

CONTACT

54-11-49635931; rodolforey@cedie.org.ar

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CEDIE

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

AR (1)