Clinical trial NCT03316482: Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Precocious Puberty
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 58
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Leuprorelin treatment
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)
timeFrame: at 24 weeks
Secondary outcomes:
measure: LH peak/FSH ratio maintained to be <1 upon
timeFrame: at 12, 24, and 48 weeks
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Hwang, Jin Soon
Study officials:
affiliation: Ajoun university hospital
name: Jin Soon Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: