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

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ClinicalTrials.gov Identifier: NCT03316482
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jin Soon Hwang, Ajou University School of Medicine

Brief 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

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Leuplin DPS 11.25mg Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Leuprorelin treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 11, 2015
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : December 30, 2019


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 Name: injection




Primary Outcome Measures :
  1. Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL) [ Time Frame: at 24 weeks ]
    Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL) maintained upon GnRH stimulation test at 12, 24, and 48 weeks


Secondary Outcome Measures :
  1. LH peak/FSH ratio maintained to be <1 upon [ Time Frame: at 12, 24, and 48 weeks ]
    Percentage(%) of subjects with a LH peak/FSH ratio maintained to be <1 upon GnRH stimulation test at 12, 24, and 48 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316482


Locations
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Korea, Republic of
Hwang, Jin Soon
Suwon-si, Korea, Republic of
Sponsors and Collaborators
Jin Soon Hwang
Investigators
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Principal Investigator: Jin Soon Hwang, MD, PhD Ajoun university hospital
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Responsible Party: Jin Soon Hwang, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03316482    
Other Study ID Numbers: LEUPLIN3M
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents