Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment (CDGP)

NCT01797718 Phase 2/Phase 3 COMPLETED

Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (\~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.

Details

Lead sponsor	Helsinki University Central Hospital
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	35
Start date	2013-10
Completion	2018-02-05

Conditions

• Constitutional Delay of Growth and Puberty

Interventions

• Testosterone
• Letrozole

Primary outcomes

• testicular volume — one year
  Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo
• clinical and biochemical measures of pubertal progression — one year
  Activity of the hypothalamic-pituitary-gonadal axis, evaluated by * genital and pubic hair stage of puberty according to Tanner; * growth velocity (cm/yr); * basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels; * urinary luteinizing hormone levels; * testosterone; * inhibin B; * anti-mullerian hormone (AMH)

Countries

Finland