Precocious Puberty, CentralCPP-LHNCT07864116
Basal LH Threshold for the Diagnosis of Central Precocious Puberty
An observational study of Precocious Puberty, Central, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Precocious Puberty, Central
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2026to 2 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children evaluated for suspected central precocious puberty in a pediatric day hospital setting, who underwent LHRH stimulation testing.
Who may be able to join
- Children aged 4 to 11 years
- Underwent LHRH stimulation testing for suspected precocious puberty between 01/01/2019 and 01/01/2024
- No written opposition to reuse of medical data
Who cannot join
- Written opposition to data reuse
- Age <4 years or >11 years 11 months
- LHRH test performed for indications other than suspected precocious puberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Sylvie Rossignol, MD, PhD, 33 3 88 12 77 34, sylvie.rossignol@chru-strasbourg.fr
Sylvie Rossignol, MD, PhD
About this study
Official title: Can LHRH Stimulation Testing Be Avoided? Evaluation of a Basal LH Threshold in Central Precocious Puberty
This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing. Currently, all patients with suspected precocious puberty undergo LHRH testing regardless of basal LH levels.
The study will analyze pediatric patients evaluated between 2019 and 2024 to determine an optimal basal LH threshold with high specificity. Secondary analyses will assess diagnostic performance and explore clinical and biological factors influencing LH levels. The results may help reduce unnecessary testing and improve diagnostic strategies.
- Conditions
- Precocious Puberty, Central
- Keywords
- Precocious puberty, Pediatric endocrinology, Diagnostic threshold
- Medical subject headings
- Puberty, Precocious
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal LH threshold for diagnosis of central precocious puberty
Determination of the basal LH level associated with a positive diagnosis of central precocious puberty (LH peak >5 IU/L) and estimation of the number of LHRH stimulation tests that could have been avoided using this threshold.
Measured: At time of diagnostic evaluation (retrospective data from 2019-2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start2 Mar 2026
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Jan 2027 (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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864116
- Sponsor's protocol ID
- RC25_0129
- Acronym
- CPP-LH
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can LHRH Stimulation Testing Be Avoided? Evaluation of a Basal LH Threshold in Central Precocious Puberty
- ClinicalTrials.gov ID
- NCT07864116
- Acronym / sponsor ID
- CPP-LH / RC25_0129
- Conditions
- Precocious Puberty, Central
- Keywords
- Precocious puberty, Pediatric endocrinology, Diagnostic threshold
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing. Currently, all patients with suspected precocious puberty undergo LHRH testing regardless of basal LH levels.
The study will analyze pediatric patients evaluated between 2019 and 2024 to determine an optimal basal LH threshold with high specificity. Secondary analyses will assess diagnostic performance and explore clinical and biological factors influencing LH levels. The results may help reduce unnecessary testing and improve diagnostic strategies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children evaluated for suspected central precocious puberty in a pediatric day hospital setting, who underwent LHRH stimulation testing.
Key inclusion criteria (3 listed)
- Children aged 4 to 11 years
- Underwent LHRH stimulation testing for suspected precocious puberty between 01/01/2019 and 01/01/2024
- No written opposition to reuse of medical data
Key exclusion criteria (3 listed)
- Written opposition to data reuse
- Age <4 years or >11 years 11 months
- LHRH test performed for indications other than suspected precocious puberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Basal LH threshold for diagnosis of central precocious puberty
Time frame: At time of diagnostic evaluation (retrospective data from 2019-2024)
Determination of the basal LH level associated with a positive diagnosis of central precocious puberty (LH peak >5 IU/L) and estimation of the number of LHRH stimulation tests that could have been avoided using this threshold.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precocious Puberty, Central, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Rossignol, MD, PhD (33 3 88 12 77 34, sylvie.rossignol@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal LH threshold for diagnosis of central precocious puberty (time frame: At time of diagnostic evaluation (retrospective data from 2019-2024)). 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 7 Oct 2026.