Precocious Puberty, CentralPhase 4NCT02974270
Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate
A Phase 4 study testing Leuprolide in people with Precocious Puberty, Central, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Precocious Puberty, Central
- What is being tested?
- Leuprolide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Mar 2018
- 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 Up to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
- Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
- Tanner stage ≥2
- Advanced bone age (Bone Age/Chronological Age >1.1)
- Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures
Who cannot join
- Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
- Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
- Currently on or planning growth hormone treatment
- Previous Gonadotropin-Releasing Hormone agonist treatment
- Any patient who in opinion of the investigator should not participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cheol Woo Ko
Daegu
Cheol Woo Ko, MD, PhD
About this study
Official title: Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate
- Conditions
- Precocious Puberty, Central
- Being tested
- Leuprolide
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide acetate | Experimental | Not described Receives: Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
Measured: 6 months
Secondary outcomes (1)
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious Puberty, CentralStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Woo Ko, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974270
- Sponsor's protocol ID
- IISR-2014-100760
- Status last verified
- Nov 2016
- First submitted
- 19 May 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
- ClinicalTrials.gov ID
- NCT02974270
- Acronym / sponsor ID
- IISR-2014-100760
- Conditions
- Precocious Puberty, Central
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- 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.
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprolide acetate | Experimental | Drug: Leuprolide |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
- Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
- Tanner stage ≥2
- Advanced bone age (Bone Age/Chronological Age >1.1)
- Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures
Key exclusion criteria (5 listed)
- Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
- Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
- Currently on or planning growth hormone treatment
- Previous Gonadotropin-Releasing Hormone agonist treatment
- Any patient who in opinion of the investigator should not participate in the study
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 |
|---|---|---|
| Leuprolide | Drug | Leuprolide acetate |
Primary outcome
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
Time frame: 6 months
1 secondary outcome
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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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.
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 Leuprolide in people with Precocious Puberty, Central, run by Kyungpook National University Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 28 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheol Woo Ko, MD, PhD (01082453633, cwko@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months (time frame: 6 months). 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 28 Nov 2016.