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Trial · NCT06294990

Registered outcomes61

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChanges in body fat massBaseline and 1 and two yearsEvaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan
SecondaryPubertal development and virilizationEvery three months for two yearsTanner genital (G) staging from G1 to G5. G1 is the prepubertal stage and G5 is the fully develloped stage.
SecondaryPubertal development and virilizationEvery three months for two yearsTanner pubic hair (PH) staging from PH1 to PH6. PH1 is the prepubertal stage and PH6 is the fully develloped stage.
SecondaryPubertal development and virilizationEvery three months for two yearsMeasurement of voice frequency using the app "Voice Analyst" (Speechtools Ltd.).
SecondaryPubertal development and virilizationEvery three months for two yearsEvaluation of testicular volume by palpation with orchidometer
SecondaryPubertal development and virilizationEvery three months for two yearsPresence of gynecomastia (yes/no)
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of luteinizing hormone (LH) (IU/L) in serum
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of serum concentration of testosterone (nmol/L)
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of folliclestimulating hormone (FSH) (IU/L) in serum
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of serum concentration of estradiol (pmol/L)
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of serum concentration of inhibin B (ng/L)
SecondaryPubertal development and viriliztionEvery three months for two yearsMeasurement of serum concentration of anti mullerian hormone (AMH) (pmol/L)
SecondaryPubertal developmentAt base line, and at 1 and 2 yearsMeasurement of the concentration of luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the first, fasting, morning voiding. Measured in IU/L.
SecondaryAnthropometryEvery three months for two yearsMeasurement of height (cm)
SecondaryAnthropometryEvery three months for two yearsMeasurement of weight (kg)
SecondaryAnthropometryEvery three months for two yearsMeasurement of sitting height (cm)
SecondaryAnthropometryAt base line, and at 1 and 2 yearsMeasurement of head circumference (cm)
SecondaryAnthropometryAt base line, and at 1 and 2 yearsMeasurement of arm span (cm)
SecondaryBone healthAt baseline and at 1 and two yearsMeasurement of whole body bone mineral content (BMC) evaluated by whole body DXA scan
SecondaryBone healthAt base line, and at 1 and 2 yearsEvaluation of bone health index (BHI) from X-ray of left hand and evaluated using the software BoneXpert version 3 (Hørsholm, Denmark)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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