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

NCT ID: NCT03316482

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2019-12-30

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

Conditions

Central Precocious Puberty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuplin DPS 11.25mg s.c. every 12 weeks

Open

Group Type: EXPERIMENTAL

Leuplin DPS 11.25mg

Intervention Type: DRUG

Leuplin DPS 11.25mg s.c. every 12 weeks

Interventions

Leuplin DPS 11.25mg

Leuplin DPS 11.25mg s.c. every 12 weeks

Intervention Type: DRUG

Other Intervention Names

injection

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jin Soon Hwang

OTHER

Sponsor Role: lead

Responsible Party

Jin Soon Hwang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jin Soon Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ajoun university hospital

Locations

Hwang, Jin Soon

Suwon, , South Korea

Countries

South Korea

Other Identifiers

LEUPLIN3M

Identifier Type: -

Identifier Source: org_study_id