Male Hypogonadism Clinical Trial
Official title:
Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism
NCT number | NCT05541172 |
Other study ID # | CEI 21-07 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | December 31, 2025 |
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.
Status | Recruiting |
Enrollment | 27 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 12 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Rodolfo Rey | Buenos Aires | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Hospital de Niños R. Gutierrez de Buenos Aires | National Agency for Scientific and Technological Promotion, Argentina |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | The number and type of adverse events at each visit. The ratio ? bone age (months)/? chronological age (months). Bone age will be considered to be accelerated if an increase of more than 12 months is found for every 6-month period of treatment, between visit 1 and visit 8, between visit 8 and visit 14, or between visit 14 and visit 20. | 2 years | |
Primary | 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 | |
Primary | Progression in the speed of growth | Height velocity calculated as ? stature (cm)/? 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 | Testosterone concentration in serum | Values will be considered to be within the target range if they are between 20 and 80 ng/dl in visits 4 and 7, between 100 and 180 ng/dl in visits 10 and 13, between 200 and 300 ng/dl in visits 16 and 19 and between 350 and 900 ng/dl in visits 22 and 25. | 2 years |
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