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

Central Precocious Puberty Clinical Trial

Official title:

A Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316482
• Other study ID #: LEUPLIN3M
• Status: Completed
• Phase: Phase 4
• Start date: June 11, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 30, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Leuplin DPS 11.25mg
Leuplin DPS 11.25mg s.c. every 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Hwang, Jin Soon	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
Jin Soon Hwang

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LH peak/FSH ratio maintained to be <1 upon	Percentage(%) of subjects with a LH peak/FSH ratio maintained to be <1 upon GnRH stimulation test at 12, 24, and 48 weeks	at 12, 24, and 48 weeks