Klinefelter Syndrome and Testosterone Treatment in Puberty

NCT06294990 | Recruiting Phase 4 DMC

• 1 other identifier: 2023-505854-16-00
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY). The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties. Participants will be randomized to two years treatment with testosterone or placebo.

Conditions

Klinefelter Syndrome

Keywords

Klinefelter syndrome; Puberty; Body composition

Outcome Measures

Primary Outcomes (1)

• Changes in body fat mass

  Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan

  Baseline and 1 and two years

Secondary Outcomes (60)

• Pubertal development and virilization

  Every three months for two years

• Pubertal development and virilization

  Every three months for two years

• Pubertal development and virilization

  Every three months for two years

• Pubertal development and virilization

  Every three months for two years

• Pubertal development and virilization

  Every three months for two years

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone gel applied to the skin

Drug: Testosterone gel

Placebo

PLACEBO COMPARATOR

Placebo gel applied to the skin

Other: Placebo

Interventions

Testosterone gel DRUG

Two years treatment with testosterone

Also known as: Testosterone

Testosterone

Placebo OTHER

Two years treatment with placebo

Also known as: Testosterone

Placebo

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ,XXY Klinefelter syndrome
• Luteinizing Hormone \> +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
• Free Testosterone\<+2 standard deviations
• Signed consent from parents

You may not qualify if:

• Previous or ongoing T treatment except for TRT because of micropenis
• Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected prostatic cancer or breast carcinoma
• Participation in any other clinical trial

Sponsors & Collaborators

• Lise Aksglæde: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• Caspersen ID, Fritzboger AFO, Petersen JH, Birkebaek N, Christensen AR, Schou AJ, Kristensen K, Ross JL, Davis S, Butler G, van Rijn S, Juul A, Aksglaede L. Effect of testosterone treatment during puberty in boys with Klinefelter syndrome (The TIPY Study): protocol for a nationwide randomised, double-blinded, placebo-controlled study. BMJ Open. 2025 Mar 15;15(3):e095628. doi: 10.1136/bmjopen-2024-095628.

  PMID: 40090688 DERIVED

MeSH Terms

Conditions

Klinefelter Syndrome

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lise Aksglaede, MD

  Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Aksglaede, MD

CONTACT

+45 35455064; lise.aksglaede@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multi-center, national, randomized, double-blind, placebo-controlled intervention study

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)