Study:
An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty
Rationale:
n/a
Purpose:
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 null
hypothesis of the study is that the proportion of patients achieving LH suppression to
prepubertal levels at Month 6 is 80%.
Study Status: Recruiting
Recruiting:
Douglas Rogers, MD 216-445-7811 rogersd@ccf.org
| Condition |
Intervention |
Phase |
|
Central Precocious Puberty |
Drug: Triptorelin 22.5 mg |
Phase 3 |
Verified by
Debiopharm S.A.
December, 2012
Sponsored by: Debiopharm S.A.
Information provided by: Debiopharm S.A.
ClinicalTrials.gov identifier: NCT01467882
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio
United States
Tala Dajani, MD., Principal Investigator
Barry Reiner, MD., Principal Investigator
Galal Salem, MD., Principal Investigator
Heidi Shea, MD., Principal Investigator
Mark Rappaport, MD., Principal Investigator
Opada Alzohaili, MD., Principal Investigator
Quentin Van Meter, MD., Principal Investigator
David Domek, MD., Principal Investigator
Katherina Harwood, MD., Principal Investigator
Kathleen Bethin, MD., Principal Investigator
Paul Kaplowitz, MD., Principal Investigator
Karen Klein, MD., Principal Investigator
Diane Merritt, MD., Principal Investigator
Susan Rose, MD., Principal Investigator
Gad Kletter, MD., Principal Investigator
Jami Josefson, MD., Principal Investigator
Javier Aisenberg, MD., Principal Investigator
Dennis Brenner, MD., Principal Investigator
Douglas Rogers, MD., Principal Investigator
Lawrence Silverman, MD., Principal Investigator
Peter Lee, MD., Principal Investigator
Ricardo Gomez, MD., Principal Investigator
Fernando Cassorla, MD., Principal Investigator
Joshua Yang, MD., Principal Investigator
Erica Eugster, MD., Principal Investigator
Oscar Flores, MD., Principal Investigator