Central Precocious Puberty
Conditions
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
Interventions
DRUGLeuplin DPS 11.25mg
Leuplin DPS 11.25mg s.c. every 12 weeks
Sponsors
Jin Soon Hwang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Leuprorelin treatment
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL) | 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
| Measure | Time frame | Description |
|---|---|---|
| LH peak/FSH ratio maintained to be <1 upon | 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 |
Countries
South Korea
Outcome results
None listed