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

NCT03316482 | Completed Phase 4

• 1 other identifier: LEUPLIN3M
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)

  Percentage(%) of subjects with inhibition of LH response (peak \<3mIU/mL) maintained upon GnRH stimulation test at 12, 24, and 48 weeks

  at 24 weeks

Secondary Outcomes (1)

• LH peak/FSH ratio maintained to be <1 upon

  at 12, 24, and 48 weeks

Study Arms (1)

Leuplin DPS 11.25mg s.c. every 12 weeks

EXPERIMENTAL

Open

Drug: Leuplin DPS 11.25mg

Interventions

Leuplin DPS 11.25mg DRUG

Leuplin DPS 11.25mg s.c. every 12 weeks

Also known as: injection

Leuplin DPS 11.25mg s.c. every 12 weeks

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jin Soon Hwang: lead

Study Sites (1)

Hwang, Jin Soon

Suwon, South Korea

Location

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Injections

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jin Soon Hwang, MD, PhD

  Ajoun university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Leuprorelin treatment

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 20, 2017
• Study Start: June 11, 2015
• Primary Completion: August 29, 2019
• Study Completion: December 30, 2019
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

KR (1)