The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Central Precocious Puberty

Treatments: Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634321

DW_LP1M002P

Details and patient eligibility

About

The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.

Enrollment: 63 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 4~8 years & tanner stage ≥ 2

Exclusion criteria

• Previous treatment with GnRH analog therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

63 participants in 1 patient group

Luphere

Experimental group

Treatment:

Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)