Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

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

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. May, 2013

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
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
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
Nancy Wright, MD., Principal Investigator
Bradley Miller, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site