Status:
COMPLETED
Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
Lead Sponsor:
Jin Soon Hwang
Conditions:
Central Precocious Puberty
Eligibility:
All Genders
4-9 years
Phase:
PHASE4
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 medicati...
Eligibility Criteria
Inclusion
- Female children aged '≥ 4 years \~ \< 9 years (8 years plus 364 days)
- Those who fall under Tanner stage 2 at least (on condition that they started to have breast budding under the age of 8)
- Female children who showed pubertal LH response to GnRH stimulation test (peak ≥ 7mIU/mL)
- Those whose bone age increased by one year or more compared to their chronological age
- Subjects and their guardians who gave written consent to participate in this study
Exclusion
- Those whose bone age is 11 years and 6 months or older
- Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
- Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
- Those who have received GnRH analog treatment
- Those who require treatment likely to influence the hypothalamic-pituitary-gonadal axis during the study period
- Those receiving growth hormone
- Those who are suspected of or diagnosed with malignant tumor
- Patients with severe renal failure or hepatic failure, whose participation in this study is impossible in the investigator's opinion
- 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
- Those who have participated in another clinical study within 90 days from the date when the IP was administered
- Those who are found to be ineligible for this study in the investigator's opinion
Key Trial Info
Start Date :
June 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03316482
Start Date
June 11 2015
End Date
December 30 2019
Last Update
June 2 2020
Active Locations (1)
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1
Hwang, Jin Soon
Suwon, South Korea