Central Precocious PubertyPhase 4NCT01634321
The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
A Phase 4 study testing Luphere depot 3.75mg(Leuprolide acetate 3.75mg) in people with Central Precocious Puberty, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with 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?
- Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Aug 2012
- 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
- 4~8 years \& tanner stage ≥ 2
Who cannot join
- Previous treatment with GnRH analog therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study
The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.
- Conditions
- Central Precocious Puberty
- Being tested
- Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luphere depot 3.75mg(Leuprolide acetate 3.75mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| Luphere | Experimental | Not described Receives: Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionAug 2012
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.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634321
- Sponsor's protocol ID
- DW_LP1M002P
- Status last verified
- Aug 2014
- First submitted
- 3 Jul 2012
- Last updated
- 4 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT01634321
- Acronym / sponsor ID
- DW_LP1M002P
- Conditions
- Central Precocious Puberty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Jul 2012 (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.
The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luphere | Experimental | Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4~8 years \& tanner stage ≥ 2
Key exclusion criteria (1 listed)
- Previous treatment with GnRH analog therapy
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 |
|---|---|---|
| Luphere depot 3.75mg(Leuprolide acetate 3.75mg) | Drug | Luphere |
Primary outcome
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
Time frame: At 24 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 4 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Luphere depot 3.75mg(Leuprolide acetate 3.75mg) in people with Central Precocious Puberty, run by Daewoong Pharmaceutical Co. LTD. 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 1 inclusion and 1 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 4 Aug 2014. 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?
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations (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 4 Aug 2014.