Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

What Was Tested

This registered phase 3 trial tested Triptorelin.

The total study duration per patient will be 12 months (48 weeks).

It had 1 arm (groups): Triptorelin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 44 actual participants took part.

It was open to people of any sex aged from 2 years up to 9 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 2-8 years inclusive (i.e. \< 9 years) for girls and 2-9 years inclusive (i.e. \< 10 years) for boys at initiation of triptorelin treatment. Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty. Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. Non-progressing isolated premature thelarche.

The full record lists 18 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-04 with completion listed for 2013-08.

It ran at 13 sites in United States (11), Chile (1) and Mexico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6 (time frame: Month 6).

It also tracked 16 secondary outcomes, for example Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12, Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12, Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12, Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12, Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12 and Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 44 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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