Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty

What Was Tested

This clinical trial, phase iii paper looks at Triptorelin.

Triptorelin is an established treatment for central precocious puberty (CPP) as 1- and 3-month formulations.

This is the first study in patients with CPP.

Who Took Part

The abstract describes 39 girls taking part.

PubMed indexes the participants as young children and children, both men and women.

Forty-four treatment naïve patients (39 girls and five boys) aged at treatment start 2-8 years for girls and 2-9 years for boys with an advancement of bone age over chronological age ≥1 year were to be included.

How the Study Was Run

The timeline in the abstract includes 48 weeks.

This was an international, non-comparative phase III study over 48 weeks.

Eighteen medical centers in the US, Chile and Mexico participated.

Triptorelin was administered im twice at an interval of 24 weeks.

LH, follicle stimulating hormone (FSH) (basal and stimulated), estradiol (girls), testosterone (boys), auxological parameters, clinical signs of puberty and safety were assessed.

What Was Measured

The subject headings attached to it are Biomarkers, Child Development, Chile, Estradiol, Follicle Stimulating Hormone, Human, Gonadotropin-Releasing Hormone and Luteinizing Hormone.

What This Means in Plain Language

This is a clinical trial, phase iii of Triptorelin in 39 girls over 48 weeks.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2016 (Journal of pediatric endocrinology & metabolism : JPEM), a journal based in Germany.

More context: the Triptorelin compound page, all human trials.