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Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

NCT02452931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-06-02

Study results available
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Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Conditions

  • Precocious Puberty, Central

Interventions

DRUG

Leuprolide Acetate 45 mg

Subcutaneous injection

Sponsors & Collaborators

  • Tolmar Inc.

    lead INDUSTRY

Principal Investigators

  • Peggy Schorr · orphan reach USA, LLC

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
2015-08-31
Primary Completion
2018-09-05
Completion
2018-09-05

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Mexico
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452931 on ClinicalTrials.gov