Klinefelter SyndromePhase 4TiPYNCT06294990
Klinefelter Syndrome and Testosterone Treatment in Puberty
A Phase 4 study testing Testosterone gel in people with Klinefelter Syndrome, run by Lise Aksglæde at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 years, men only
- Conditions the study is for
- Klinefelter Syndrome
- What is being tested?
- Testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2024to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 47,XXY Klinefelter syndrome
- Age 10-14 years at inclusion
- Luteinizing Hormone > +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
- Free Testosterone<+2 standard deviations
- Signed consent from parents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Lise Aksglaede, MD, +45353550564, lise.aksglaede@regionh.dk
About this study
Official title: Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'
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.
Read the detailed description
Klinefelter syndrome (KS, 47,XXY) is the most frequent sex chromosome disorder with a prevalence of 1:660 boys. Patients with KS are hypogonadal due to a progressive testicular destruction starting already in childhood. Consequently, the adult male with KS is characterized by small testes, signs of incomplete virilization (e.g. lack of voice deepening, sparse face and body hair, gynecomastia, low muscle mass, reduced penile length), hypergonadotropic hypogonadism, infertility and increased risk of metabolic syndrome, diabetes, cardiovascular disease, osteoporosis and psychosocial and neurodevelopmental challenges. Adults with KS have a poor health and a prevention of the major co-morbidities associated with KS and thereby an improvement in the general health would have an enormous impact on the life of a large cohort of males worldwide.
Sufficient testosterone is not only important in the adult but also during puberty and adolescence for a normal virilization and to improve body composition and body proportions, as well as to maximize peak bone mass acquisition. It has therefore been internationally accepted and makes biological sense to consider testosterone replacement therapy (TRT) during puberty in KS. However, there are no evidence based recommendations, and during recent years TRT in puberty has been questioned and is no longer recommended in some countries. There is a need on an international level for evaluating the effect of this treatment. We therefore aim at evaluating the effect of 2 years TRT during early puberty in boys with KS aged 10 to 14 years in this national, multi-center, randomized, double-blind, placebo-controlled intervention study. The primary endpoint is to evaluate the effect on body fat mass. The secondary endpoints are to evaluate effects on lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.
- Conditions
- Klinefelter Syndrome
- Being tested
- Testosterone gel, Placebo
- Keywords
- Klinefelter syndrome, Puberty, Body composition
- Medical subject headings
- Klinefelter Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called Testosterone
Two years treatment with testosterone
PlaceboOther
Also called Testosterone
Two years treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Active comparator | Testosterone gel applied to the skin Receives: Drug: Testosterone gel |
| Placebo | Placebo comparator | Placebo gel applied to the skin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body fat mass
Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan
Measured: Baseline and 1 and two years
Secondary outcomes (60)
Pubertal development and virilization
Tanner genital (G) staging from G1 to G5. G1 is the prepubertal stage and G5 is the fully develloped stage.
Measured: Every three months for two years
Pubertal development and virilization
Tanner pubic hair (PH) staging from PH1 to PH6. PH1 is the prepubertal stage and PH6 is the fully develloped stage.
Measured: Every three months for two years
Pubertal development and virilization
Measurement of voice frequency using the app "Voice Analyst" (Speechtools Ltd.).
Measured: Every three months for two years
Pubertal development and virilization
Evaluation of testicular volume by palpation with orchidometer
Measured: Every three months for two years
Pubertal development and virilization
Presence of gynecomastia (yes/no)
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of luteinizing hormone (LH) (IU/L) in serum
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of serum concentration of testosterone (nmol/L)
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of folliclestimulating hormone (FSH) (IU/L) in serum
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of serum concentration of estradiol (pmol/L)
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of serum concentration of inhibin B (ng/L)
Measured: Every three months for two years
Pubertal development and viriliztion
Measurement of serum concentration of anti mullerian hormone (AMH) (pmol/L)
Measured: Every three months for two years
Pubertal development
Measurement of the concentration of luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the first, fasting, morning voiding. Measured in IU/L.
Measured: At base line, and at 1 and 2 years
Anthropometry
Measurement of height (cm)
Measured: Every three months for two years
Anthropometry
Measurement of weight (kg)
Measured: Every three months for two years
Anthropometry
Measurement of sitting height (cm)
Measured: Every three months for two years
Anthropometry
Measurement of head circumference (cm)
Measured: At base line, and at 1 and 2 years
Anthropometry
Measurement of arm span (cm)
Measured: At base line, and at 1 and 2 years
Bone health
Measurement of whole body bone mineral content (BMC) evaluated by whole body DXA scan
Measured: At baseline and at 1 and two years
Bone health
Evaluation of bone health index (BHI) from X-ray of left hand and evaluated using the software BoneXpert version 3 (Hørsholm, Denmark)
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of 25-OH-vitamin D in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of calcium in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of phosphate in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of parathyroid hormone (PTH) in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of carboxy terminal telopeptide of collagen type I (CTX) in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of alkaline phosphatase in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of osteocalcin in blood sample
Measured: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Measurement of procollagen type I N-terminal peptide (PINP) in blood sample
Measured: At base line, and at 1 and 2 years
Changes in growth
Evaluation of bone age by X-ray of left hand and evaluated using the software BoneXpert version 3 (Hørsholm, Denmark)
Measured: Base line and at 1 and 2 years
Measurement of serum concentrations of growth factors
Measurement of IGF1, IGF2, IGF1BP-1-6 and acid-labile subunit (ALS)) (microg/L)
Measured: At base line, and at 1 and 2 years
Muscle strength
Measurement of standing jump length (cm)
Measured: Every three months for two years
Muscle strength
Measurement of hand grip strength using a digital hand dynamometer (Baseline BIMS, digital hand dynamometer, functional model)
Measured: Every three months for two years
Changes i QTc
Evaluation of QT Interval with electrocardiogram (ECG)
Measured: Base line and at 1 and 2 years
Changes in markers of lipids
Measurement of cholesterol in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of metabolism
Measurement of adiponectin in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of metabolism
Measurement of leptin in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of metabolism
Measurement of glucose in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of metabolism
Measurement of insulin in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of metabolism
Measurement of HbA1C in blood sample
Measured: Base line and at 1 and 2 years
Changes in markers of inflammation
Measurement of CRP in blood sample
Measured: Base line and at 1 and 2 years
Neuropsychological evaluation
The Weschler Intelligence Scale for Children - Fifth Edition (WISC-V). The result is based on a combination of seperate index scores. A higher score generally indicates stronger cognitive abilities.
Measured: Baseline and after two years
Neuropsychological evaluation
The Test of Variables of Attention, version 9 (T.O.V.A) is a computerized, performance-based assessment tool used to measure attention and impulsivity. The result is based on a combination of scores.
Measured: Baseline and after two years
Neuropsychological evaluation
The Test of Memory and Learning, Second Edition (Tomal-2). The results are presented as standard scores, scaled scores, percentile ranks, and index scores. A higher score is a better outcome.
Measured: Baseline and after two years
Neuropsychological evaluation
The Judgement of Line Orientation Test. The result is based on a combination of scores. Higher scores indicate better visual-spatial judgment.
Measured: Baseline and after two years
Neuropsychological evaluation
The Mental Rotation Test
Measured: Baseline and after two years
Neuropsychological evaluation
The Beery-Buktenica Developmental Test of Visual-Motor Integration
Measured: Baseline and after two years
Neuropsychological evaluation
The Baseline Speed subtask of the Amsterdam Neuropsychological Tasks program (ANT)
Measured: Baseline and after two years
Neuropsychological evaluation
The Children's Communication Checklist (CCC-2). The result is evaluated based on 10 subscores. Higher scores indicate stronger communication skills.
Measured: Baseline and after two years
Neuropsychological evaluation
The Social Responsiveness Scale-2 (SRS-2) is a standardized questionnaire used to assess social behavior and autism-related traits. Higher scores indicate greater social difficulties, while lower scores suggest stronger social skills.
Measured: Baseline and after two years
Neuropsychological evaluation
The Delis-Kaplan Executive Function System (D-KEFS). Higher scores indicate better executive functioning, while lower scores may suggest difficulties with problem-solving, impulse control, or flexibility.
Measured: Baseline and after two years
Neuropsychological evaluation
The Behavior Rating Inventory of Executive Function, Second Edition rating scale , parent version (BRIEF-2) assesses executive functioning. The result is based on a combination of scores. Higher scores indicate greater executive function difficulties.
Measured: Baseline and after two years
Neuropsychological evaluation
Behavior Assessment System for Children, Third Edition (BASC-3), parent and self-report version. The result is based on a combination of scores. A higher score indicates more difficulties.
Measured: Baseline and after two years
Neuropsychological evaluation
Self-report version of The Multidimensional Anxiety Scale for Children - 2nd edition (MASC-2). The result is based on a combination of scores. Higher scores suggest greater levels of anxiety and more severe symptoms.
Measured: Baseline and after two years
Neuropsychological evaluation
The parent version of the ADHD-rating scale. The result is based on a combination of scores. Higher scores on the inattention and hyperactivity/impulsivity subscales suggest more significant ADHD symptoms.
Measured: Baseline and after two years
Neuropsychological evaluation
The Adaptive Behavior Assessment System, Third Edition (ABAS-III) is a comprehensive tool used to assess adaptive functioning. The result is based on a combination of scores. A higher score indicates better adaptive functioning.
Measured: Baseline and after two years
Neuropsychological evaluation
The Beck Youth Self-Concept Inventory is a tool designed to assess self-concept and self-esteem in children and adolescents. A high percentile rank (above 70) indicates a strong self-concept, while a low percentile rank (below 30) suggests low self-esteem or dissatisfaction.
Measured: Baseline and after two years
Neuropsychological evaluation
PedsQL Multidimentional Fatigue Scale, parent, and self-report versions is a tool designed to assess fatigue levels in children and adolescents. The result is based on a combination of scores. A higher score indicates less fatigue (better energy levels and functioning). A lower score indicates more fatigue, suggesting that fatigue is significantly affecting the child's daily activities.
Measured: Baseline and after two years
Cryopreservation of spermatozoa
If the patient is able and willing he will have the possibility to deliver a semen sample for cryopreservation of potential spermatozoa
Measured: After 2 years
Epigenetic
The effects on epigenetics will be evaluation by evaluating changes in DNA methylation patterns. This will be analyzed on DNA from white blood cells by applying Illumina methylation arrays.
Measured: At base line, and at 1 and 2 years
Genetic effects
DNA will be analyzed using a selected set of genetic polymorphisms in target genes with established or theoretic effects on hormone production and hormone receptor sensitivity. They will be analysed either by PCR genotyping or targeted sequencing (max. 200 selected genes). SNP arrays that exclusively target common variants, and not any rare variants, will be used to determine the influence of common genetic variation on the observed associations.
Measured: At base line, and at 1 and 2 years
Small non-coding RNA
RNA analysis of circulating, small, non-coding RNA will be performed as a biomarker for the circulating concentrations of reproductive hormones and for overweight.
Measured: At base line, and at 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Aug 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Klinefelter SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, national, randomized, double-blind, placebo-controlled intervention study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lise Aksglæde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lise Aksglæde, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lise Aksglaede, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294990
- Sponsor's protocol ID
- 2023-505854-16-00
- Other IDs
- 2023
- Acronym
- TiPY
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40090688
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'
- ClinicalTrials.gov ID
- NCT06294990
- Acronym / sponsor ID
- TiPY / 2023-505854-16-00
- Conditions
- Klinefelter Syndrome
- Keywords
- Klinefelter syndrome, Puberty, Body composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Lise AksglædeUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Klinefelter syndrome (KS, 47,XXY) is the most frequent sex chromosome disorder with a prevalence of 1:660 boys. Patients with KS are hypogonadal due to a progressive testicular destruction starting already in childhood. Consequently, the adult male with KS is characterized by small testes, signs of incomplete virilization (e.g. lack of voice deepening, sparse face and body hair, gynecomastia, low muscle mass, reduced penile length), hypergonadotropic hypogonadism, infertility and increased risk of metabolic syndrome, diabetes, cardiovascular disease, osteoporosis and psychosocial and neurodevelopmental challenges. Adults with KS have a poor health and a prevention of the major co-morbidities associated with KS and thereby an improvement in the general health would have an enormous impact on the life of a large cohort of males worldwide.
Sufficient testosterone is not only important in the adult but also during puberty and adolescence for a normal virilization and to improve body composition and body proportions, as well as to maximize peak bone mass acquisition. It has therefore been internationally accepted and makes biological sense to consider testosterone replacement therapy (TRT) during puberty in KS. However, there are no evidence based recommendations, and during recent years TRT in puberty has been questioned and is no longer recommended in some countries. There is a need on an international level for evaluating the effect of this treatment. We therefore aim at evaluating the effect of 2 years TRT during early puberty in boys with KS aged 10 to 14 years in this national, multi-center, randomized, double-blind, placebo-controlled intervention study. The primary endpoint is to evaluate the effect on body fat mass. The secondary endpoints are to evaluate effects on lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multi-center, national, randomized, double-blind, placebo-controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Active comparator | Drug: Testosterone gelTestosterone gel applied to the skin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo gel applied to the skin |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 47,XXY Klinefelter syndrome
- Age 10-14 years at inclusion
- Luteinizing Hormone > +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
- Free Testosterone<+2 standard deviations
- Signed consent from parents
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gelAlso: TestosteroneTwo years treatment with testosterone | Drug | Testosterone |
| PlaceboAlso: TestosteroneTwo years treatment with placebo | Other | Placebo |
Primary outcome
Changes in body fat mass
Time frame: Baseline and 1 and two years
Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan
60 secondary outcomes
Pubertal development and virilization
Time frame: Every three months for two years
Pubertal development and virilization
Time frame: Every three months for two years
Pubertal development and virilization
Time frame: Every three months for two years
Pubertal development and virilization
Time frame: Every three months for two years
Pubertal development and virilization
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development and viriliztion
Time frame: Every three months for two years
Pubertal development
Time frame: At base line, and at 1 and 2 years
Anthropometry
Time frame: Every three months for two years
Anthropometry
Time frame: Every three months for two years
Anthropometry
Time frame: Every three months for two years
Anthropometry
Time frame: At base line, and at 1 and 2 years
Anthropometry
Time frame: At base line, and at 1 and 2 years
Bone health
Time frame: At baseline and at 1 and two years
Bone health
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Measurement of bone turnover markers
Time frame: At base line, and at 1 and 2 years
Changes in growth
Time frame: Base line and at 1 and 2 years
Measurement of serum concentrations of growth factors
Time frame: At base line, and at 1 and 2 years
Muscle strength
Time frame: Every three months for two years
Muscle strength
Time frame: Every three months for two years
Changes i QTc
Time frame: Base line and at 1 and 2 years
Changes in markers of lipids
Time frame: Base line and at 1 and 2 years
Changes in markers of metabolism
Time frame: Base line and at 1 and 2 years
Changes in markers of metabolism
Time frame: Base line and at 1 and 2 years
Changes in markers of metabolism
Time frame: Base line and at 1 and 2 years
Changes in markers of metabolism
Time frame: Base line and at 1 and 2 years
Changes in markers of metabolism
Time frame: Base line and at 1 and 2 years
Changes in markers of inflammation
Time frame: Base line and at 1 and 2 years
Neuropsychological evaluation
Time frame: Baseline and after two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 40090688Caspersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lise Aksglaede, MD principal investigator
Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone gel in people with Klinefelter Syndrome, run by Lise Aksglæde at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Aksglaede, MD (+45 35455064, lise.aksglaede@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body fat mass (time frame: Baseline and 1 and two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06294990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.