NCT01634321

Brief Summary

The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

July 3, 2012

Last Update Submit

August 1, 2014

Conditions

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

  • At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations

    At 24 weeks

Study Arms (1)

Luphere

EXPERIMENTAL
Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

Interventions

Luphere depot 3.75mg(Leuprolide acetate 3.75mg)DRUG
Luphere

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \~8 years \& tanner stage ≥ 2

You may not qualify if:

  • Previous treatment with GnRH analog therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University medical center

Soo-won, South Korea

Location

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

KR(1)