A 6-Month Trial of the Efficacy and Safety of Triptorelin Pamoate (11.25 mg) Every 3 Months in Children with Precocious Puberty: A Retrospective Comparison with Triptorelin Acetate.
OBJECTIVE
To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP) (TP Study) and to retrospectively compare it with a triptorelin acetate (11.25 mg) 3-month formulation (TA Study).


METHODS
We conducted two phase III, multicentre, single-stage, non-comparative, open-label studies. In the TP Study, patients with CPP received an intramuscular injection of triptorelin pamoate 11.25 mg at baseline and 3 months after baseline. Hormonal changes as well as safety and efficacy endpoints were measured at baseline, 3 months, and 6 months.


RESULTS
The baseline characteristics of the 37 patients in the TP Study were similar to those of the TA Study population. A suppressed luteinising hormone (LH) response (LH peak ≤3 IU/l) to the gonadotrophin-releasing hormone test at 3 months (primary endpoint) occurred in 83.8 and 82.8% of the cases in the TP and the TA Study, respectively. At 6 months, a suppressed LH response occurred in 86.5 and 96.8% of the cases in the TP and the TA Study, respectively. Pubertal development was slowed in both studies. Adverse events were mild to moderate and resolved without sequelae in the TP Study.


CONCLUSIONS
Triptorelin pamoate 11.25 mg administered at 3-month intervals is an effective and well-tolerated treatment in patients with CPP. The efficacy and safety profiles appear similar to those reported in the literature for triptorelin acetate 11.25 mg. © 2016 S. Karger AG, Basel.
Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
Delphine
D
Zenaty
Joelle
J
Blumberg
Nilani
N
Liyanage
Evelyne
E
Jacqz-Aigrain
Najiba
N
Lahlou
Jean-Claude
JC
Carel
D002648:Child; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D011629:Puberty, Precocious / Q000097:blood / Q000188:drug therapy*; D012189:Retrospective Studies; D013997:Time Factors; D017329:Triptorelin Pamoate / Q000008:administration & dosage* / Q000009:adverse effects
D017329:Triptorelin Pamoate; D007987:Gonadotropin-Releasing Hormone; D007986:Luteinizing Hormone