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NCT03325647: TESTO
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY
Phase 4 trial testing Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution in Klinefelter Syndrome in 72 participants. Completed in 5 May 2021.
5 May 2021
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 6 November 2017 |
| Primary completion | 5 May 2021 |
| Estimated completion | 5 May 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution — full drug profile →
- Placebo injectable saline — full drug profile →
Conditions studied
- Klinefelter Syndrome — all drugs for Klinefelter Syndrome →
Sponsor
University of Colorado, Denver
Who can join
Adults 31 Days to 90 Days, male only, with Klinefelter Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about the effect of testosterone on early health and development. The study is a total of three visits over 6 months with assessments of motor skills, body composition (muscle and fat), and hormone levels. This is a randomized, placebo-controlled study but all infants will receive testosterone treatment during the study period. The investigators will learn how testosterone treatment in infancy effects short term outcome measures on health and development.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Testosterone Treatment in Infants With 47,XXY: Effects on Body Composition.
Davis SM, Reynolds RM, Dabelea DM, Zeitler PS, et al · · 2019 · cited 28× · PMID 31737857 · DOI 10.1210/js.2019-00274 -
Morbidity in Klinefelter syndrome and the effect of testosterone treatment.
Chang S, Skakkebaek A, Davis SM, Gravholt CH. · · 2020 · cited 27× · PMID 32496001 · DOI 10.1002/ajmg.c.31798 -
Minipuberty in Klinefelter syndrome: Current status and future directions.
Aksglaede L, Davis SM, Ross JL, Juul A. · · 2020 · cited 27× · PMID 32476267 · DOI 10.1002/ajmg.c.31794 -
Early developmental impact of sex chromosome trisomies on attention deficit-hyperactivity disorder symptomology in young children.
Kuiper K, Swaab H, Tartaglia N, van Rijn S. · · 2021 · cited 19× · PMID 34240550 · DOI 10.1002/ajmg.a.62418 -
The developmental impact of sex chromosome trisomies on emerging executive functions in young children: Evidence from neurocognitive tests and daily life skills.
Kuiper KC, Swaab H, Tartaglia N, van Buggenhout G, et al · · 2022 · cited 8× · PMID 35584398 · DOI 10.1111/gbb.12811 -
Early symptoms of autism spectrum disorder (ASD) in 1-8 year old children with sex chromosome trisomies (XXX, XXY, XYY), and the predictive value of joint attention.
Bouw N, Swaab H, Tartaglia N, Wilson RL, et al · · 2023 · cited 7× · PMID 36107256 · DOI 10.1007/s00787-022-02070-y -
(Not) getting what you want: frustration and emotion regulation in children with sex chromosome trisomies.
Kuiper K, Swaab H, Tartaglia N, van Rijn S. · · 2023 · cited 1× · PMID 37183811 · DOI 10.1530/ec-22-0442
Verify or expand the search:
- PubMed search for NCT03325647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Klinefelter Syndrome
Currently open trials in the same condition.
- NCT06294990 — Klinefelter Syndrome and Testosterone Treatment in Puberty · Phase 4 · recruiting
- NCT05586802 — Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome · Phase 3 · recruiting
- NCT05498090 — Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome · Phase 4 · active not recruiting
- NCT03396562 — The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Ch · recruiting
- NCT05581147 — Thyroid Function and Structure in Klinefelter Syndrome · recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03325647 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 6 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03325647.
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