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

Summary

The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).

Conditions

• Central Precocious Puberty

Interventions

DRUG

Triptorelin

Powder and solution for solution for injection

Sponsors & Collaborators

• Debiopharm International SA

  lead INDUSTRY

Principal Investigators

• Tala Dajani, MD · Pediatric Endocrinology of Phoenix, Arizona

• Barry Reiner, MD · Barry J. Reiner, MD, LLC, Baltimore, Maryland

• Galal Salem, MD · SRCR, Inc, Bell Gardens, California

• Heidi Shea, MD · Endocrine Associates of Dallas, Plano, Texas

• Mark Rappaport, MD · Pediatric Endocrine Associates, Atlanta, Georgia

• Opada Alzohaili, MD · Alzohaili Medical Consultants, Dearborn, Michigan

• Quentin Van Meter, MD · Van Meter Pediatric Endocrinology, Peachtree City, Georgia

• David Domek, MD · Lynn health Science Institute, Oklahoma City

• Kathleen Bethin, MD · Women's & Children's Hospital of Buffalo, New York

• Paul Kaplowitz, MD · Children's National Medical Center, Washington

• Karen Klein, MD · Children's National Medical Center, San Diego, California

• Diane Merritt, MD · Washington University, St. Louis, Missouri

• Susan Rose, MD · Cincinnati Children's Hospital, Ohio

• Gad Kletter, MD · Swedish Pediatric Specialist, Seattle, Washington

• Javier Aisenberg, MD · Hackensack university medical center, New Jersey

• Dennis Brenner, MD · St. Barnabas Medical Center, Livingston, New Jersey

• Douglas Rogers, MD · Cleveland Clinic, Ohio

• Lawrence Silverman, MD · Goryeb Children's Hospital, Morristown, New Jersey

• Peter Lee, MD · Penn State Hershey Children's Hospital, Pennsylvania

• Ricardo Gomez, MD · Children's Hospital, New Orleans, Louisiana

• Fernando Cassorla, MD · IDIMI, Santiago, Chile

• Joshua Yang, MD · Arnold Palmer Pediatric Endocrinology Practice, Orlando, Florida

• Erica Eugster, MD · James Whitcomb Riley Hospital for Children, Indianapolis, Indiana

• Oscar Flores, MD · Hospital Universitario de Monterrey, Mexico

• Nancy Wright, MD · Nancy Wright MD P.A., Tallahasse, Florida

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-08-31

Completion

2014-07-31

Countries

• United States
• Chile
• Mexico

Study Locations