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

A Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty

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

Study Overview

• Status: Completed
• Conditions: Central Precocious Puberty
• Intervention / Treatment: Drug: Leuplin DPS 11.25mg

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • Hwang, Jin Soon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leuplin DPS 11.25mg s.c. every 12 weeks; Open	Drug: Leuplin DPS 11.25mg; Leuplin DPS 11.25mg s.c. every 12 weeks; Other Names: injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 12, 24, and 48 weeks

Collaborators and Investigators

• Sponsor: Jin Soon Hwang
• Investigators: Principal Investigator: Jin Soon Hwang, MD, PhD, Ajoun university hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: LEUPLIN3M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No