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CompletedNCT01634321Updated Aug 4, 2014

The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty

A Phase 4 interventional study of Luphere depot 3.75mg(Leuprolide acetate 3.75mg) in Central Precocious Puberty, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2014-08-04.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Central Precocious Puberty

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03

In context

Puberty, Precocious

75 studies on the registry are indexed under Puberty, Precocious; 19 are open to participants now.

This study's enrollment of 63 is close to the median of 64 across 47 interventional studies indexed under Puberty, Precocious.

Browse Puberty, Precocious studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 4\~8 years \& tanner stage ≥ 2

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with GnRH analog therapy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Luphere

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

Interventions

  • DrugLuphere depot 3.75mg(Leuprolide acetate 3.75mg)
06

What researchers measure

Primary outcomes

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

    Time frame: At 24 weeks

07

Study locations

1 site
  • Ajou University medical center
    Soo-won, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01634321
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jul 6, 2012
Start date
Jul 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Aug 4, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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