Overview

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

Status:
Completed
Trial end date:
2019-12-30
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jin Soon Hwang
Treatments:
Leuprolide
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