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CompletedNCT03316482Updated Jun 2, 2020

Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty

A Phase 4 interventional study of Leuplin DPS 11.25mg in Central Precocious Puberty, sponsored by Jin Soon Hwang. Completed at 1 site in Korea, Republic of. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2020-06-02.

Sponsored by Jin Soon Hwang · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jun 2015, registered Oct 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
4 Years to 9 Years
Sex
All
01

Study summary

A multicenter, open-label, prospective study to evaluate the safety and efficacy of leuprorelin acetate DPS (Leuplin DPS) treatment quarterly in patients with central precocious puberty

Read the detailed description

Type and design of study (eg, parallel, crossover, double-blind, open, superiority, noninferiority).Blinding measures taken to minimize bias (eg, "single-blind; subjects receive blinded study medication").

A single arm, multicenter, open-label, prospective study. Requirements for run-in or washout of medication. Those who have been administered one of the following drugs within 2 weeks before they start to participate in this study

  • Estrogens
  • Antiestrogens
  • Progesterones
  • Steroids
  • Oriental medicines

Description of population to be studied (eg, adults with chronic heart failure and ejection fraction below 40% or subjects with uncontrolled, long-term type 2 diabetes).

Children with central precocious puberty

  • Inclusion Criteria.

    1. Female children aged '≥ 4 years \~ \< 9 years (8 years plus 364 days)
    2. Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
    3. Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
    4. Those whose bone age increased by one year or more compared to their chronological age
    5. Subjects and their guardians who gave written consent to participate in this study

  • Exclusion Criteria.

    1. Those whose bone age is 11 years and 6 months or older
    2. Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
    3. Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
    4. Those who have received GnRH analog treatment
    5. Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
    6. Those receiving growth hormone
    7. Those who are suspected of or diagnosed with malignant tumor
    8. Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion

    9. Those who have been administered one of the following drugs within 2 weeks before they started to participate in this study, or who are expected to be administered during the study period

      • Estrogens
      • Antiestrogens
      • Progesterones
      • Steroids
      • Oriental medicines
    10. Those who have participated in another clinical study within 90 days from the date when the IP was administered
    11. Those who are found to be ineligible for this study in the investigator's opinion
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; 18 are open to participants now.

This study's enrollment of 58 is close to the median of 64 across 47 interventional studies indexed under Puberty, Precocious.

Browse Puberty, Precocious studies →

Lead sponsor

This is the only study on the registry with Jin Soon Hwang as lead sponsor.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female children aged '≥ 4 years \~ \< 9 years (8 years plus 364 days)
  2. Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
  3. Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
  4. Those whose bone age increased by one year or more compared to their chronological age
  5. Subjects and their guardians who gave written consent to participate in this study

Exclusion criteria

Exclusion Criteria:

  1. Those whose bone age is 11 years and 6 months or older
  2. Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
  3. Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
  4. Those who have received GnRH analog treatment
  5. Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
  6. Those receiving growth hormone
  7. Those who are suspected of or diagnosed with malignant tumor
  8. Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion

  9. Those who have been administered one of the following drugs within 2 weeks before they started to participate in this study, or who are expected to be administered during the study period

    • Estrogens
    • Antiestrogens
    • Progesterones
    • Oriental medicines
  10. Those who have participated in another clinical study within 90 days from the date when the IP was administered
  11. Those who are found to be ineligible for this study in the investigator's opinion
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Leuplin DPS 11.25mg s.c. every 12 weeks

    Open

    Drug: Leuplin DPS 11.25mg

Interventions

  • DrugLeuplin DPS 11.25mg

    Leuplin DPS 11.25mg s.c. every 12 weeks

    Also known as: injection

06

What researchers measure

Primary outcomes

  1. Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)

    Percentage(%) of subjects with inhibition of LH response (peak \<3mIU/mL) maintained upon GnRH stimulation test at 12, 24, and 48 weeks

    Time frame: at 24 weeks

Secondary outcomes

  1. LH peak/FSH ratio maintained to be <1 upon

    Percentage(%) of subjects with a LH peak/FSH ratio maintained to be \<1 upon GnRH stimulation test at 12, 24, and 48 weeks

    Time frame: at 12, 24, and 48 weeks

07

Study locations

1 site
  • Hwang, Jin Soon
    Suwon-si, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03316482
Lead sponsor
Jin Soon Hwang
Responsible party
Jin Soon Hwang (Professor, Ajou University School of Medicine) — Sponsor-investigator
First posted
Oct 20, 2017
Start date
Jun 11, 2015
Primary completion
Aug 29, 2019
Completion
Dec 30, 2019
Last update
Jun 2, 2020

Study contacts

Jin Soon Hwang, MD, PhD
principal investigator · Ajoun university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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