Central Precocious PubertyPhase 4NCT03316482
Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
A Phase 4 study testing Leuplin DPS 11.25mg in people with Central Precocious Puberty, run by Jin Soon Hwang at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Central Precocious Puberty
- What is being tested?
- Leuplin DPS 11.25mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2015to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Those who are found to be ineligible for this study in the investigator's opinion
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- 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
- Exclusion Criteria.
- 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
- Those who are found to be ineligible for this study in the investigator's opinion
- Conditions
- Central Precocious Puberty
- Being tested
- Leuplin DPS 11.25mg
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuplin DPS 11.25mgDrug
Also called injection
Leuplin DPS 11.25mg s.c. every 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Leuplin DPS 11.25mg s.c. every 12 weeks | Experimental | Open Receives: Drug: Leuplin DPS 11.25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 weeks
Secondary outcomes (1)
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
Measured: at 12, 24, and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start11 Jun 2015
- Primary completion29 Aug 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Leuprorelin treatment
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin Soon Hwang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Soon Hwang, Ajou University School of Medicine
- Investigators
- Jin Soon Hwang, MD, PhD, Principal investigator, Ajoun university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316482
- Sponsor's protocol ID
- LEUPLIN3M
- Status last verified
- May 2020
- First submitted
- 12 Oct 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03316482
- Acronym / sponsor ID
- LEUPLIN3M
- Conditions
- Central Precocious Puberty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jin Soon HwangUniversity, hospital or other
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Exclusion Criteria.
- 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
- Those who are found to be ineligible for this study in the investigator's opinion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Leuprorelin treatment
| Arm | Type | Receives |
|---|---|---|
| Leuplin DPS 11.25mg s.c. every 12 weeks | Experimental | Drug: Leuplin DPS 11.25mgOpen |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuplin DPS 11.25mgAlso: injectionLeuplin DPS 11.25mg s.c. every 12 weeks | Drug | Leuplin DPS 11.25mg s.c. every 12 weeks |
Primary outcome
Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)
Time frame: at 24 weeks
Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL) maintained upon GnRH stimulation test at 12, 24, and 48 weeks
1 secondary outcome
LH peak/FSH ratio maintained to be <1 upon
Time frame: at 12, 24, and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Soon Hwang, MD, PhD principal investigator
Ajoun university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leuplin DPS 11.25mg in people with Central Precocious Puberty, run by Jin Soon Hwang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL) (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.