COVID19- Infection with SARS-CoV-2 VirusCOVID-19-PPNCT06823076
Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey
An observational study of COVID19- Infection with SARS-CoV-2 Virus, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages Up to 18 years, women only
- Conditions the study is for
- COVID19- Infection with SARS-CoV-2 Virus
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2023
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study included patients admitted to the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital and Suleyman Demirel University, located in two different cities in Turkey. These patients were diagnosed with precocious puberty and treated with GnRH analogs before and after the COVID-19 pandemic. The patients were categorized into two groups: the pre-pandemic group (admitted and started GnRH analog treatment between March 2018 and March 2020) and the pandemic group (admitted and started GnRH analog treatment between March 2020 and March 2022), covering 24 months before and after the start of the pandemic lockdown
Who may be able to join
- Girls: Tanner stage ≥2 before age 8 peak LH > on gnrh analog test, basal Lh >0,3
- Patients with organic lesions (e.g., hypothalamo-pituitary tumors), congenital malformations, oncological diseases, neurosurgical or genetic disorders, or medications affecting puberty were excluded from the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital
Istanbul, Istanbul, 34764
About this study
Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic.
Read the detailed description
Methods: A retrospective cohort study was conducted on patients admitted to the Pediatric Endocrinology Departments of two centers in Turkey. Girls treated with GnRH analogs between March 2018 and 2022 were categorized into two groups: the pre-pandemic group (2018-2020) and the pandemic group (2020-2022). Clinical, anthropometric, and hormonal data were analyzed. Patients with organic lesions, genetic conditions, or medications affecting puberty were excluded.
- Conditions
- COVID19- Infection with SARS-CoV-2 Virus
- Keywords
- Central precocious puberty, COVID-19 pandemic, GnRH analogs, pediatric endocrinology, lifestyle changes
- Medical subject headings
- Puberty, Precocious, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prepandemic and pandemic precocious puberty groups were compared | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Age at Pubertal Onset
Mean Age at Pubertal Onset
Description: The mean age at pubertal onset will be compared between pre-pandemic and post-pandemic periods in both girls and boys.
Time Frame: At baseline. Method of Measurement: Tanner staging, LH/FSH levels, and bone age assessment.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Mar 2018
- Primary completion1 Mar 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19- Infection with SARS-CoV-2 VirusStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, gulcan seymen, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823076
- Sponsor's protocol ID
- 406240
- Acronym
- COVID-19-PP
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Only aggregated study results will be published in peer-reviewed journals."
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey
- ClinicalTrials.gov ID
- NCT06823076
- Acronym / sponsor ID
- COVID-19-PP / 406240
- Conditions
- COVID19- Infection with SARS-CoV-2 Virus
- Keywords
- Central precocious puberty, COVID-19 pandemic, GnRH analogs, pediatric endocrinology, lifestyle changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 12 Feb 2025 (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.
Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic.
Detailed description
Methods: A retrospective cohort study was conducted on patients admitted to the Pediatric Endocrinology Departments of two centers in Turkey. Girls treated with GnRH analogs between March 2018 and 2022 were categorized into two groups: the pre-pandemic group (2018-2020) and the pandemic group (2020-2022). Clinical, anthropometric, and hormonal data were analyzed. Patients with organic lesions, genetic conditions, or medications affecting puberty were excluded.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prepandemic and pandemic precocious puberty groups were compared | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study included patients admitted to the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital and Suleyman Demirel University, located in two different cities in Turkey. These patients were diagnosed with precocious puberty and treated with GnRH analogs before and after the COVID-19 pandemic. The patients were categorized into two groups: the pre-pandemic group (admitted and started GnRH analog treatment between March 2018 and March 2020) and the pandemic group (admitted and started GnRH analog treatment between March 2020 and March 2022), covering 24 months before and after the start of the pandemic lockdown
Key inclusion criteria (2 listed)
- Girls: Tanner stage ≥2 before age 8 peak LH > on gnrh analog test, basal Lh >0,3
- Patients with organic lesions (e.g., hypothalamo-pituitary tumors), congenital malformations, oncological diseases, neurosurgical or genetic disorders, or medications affecting puberty were excluded from the study
Key exclusion criteria (0 listed)
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
Mean Age at Pubertal Onset
Time frame: 4 years
Mean Age at Pubertal Onset Description: The mean age at pubertal onset will be compared between pre-pandemic and post-pandemic periods in both girls and boys. Time Frame: At baseline. Method of Measurement: Tanner staging, LH/FSH levels, and bone age assessment.
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 12 Feb 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies. Only aggregated study results will be published in peer-reviewed journals."
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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?
An observational study of COVID19- Infection with SARS-CoV-2 Virus, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 0 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 12 Feb 2025. 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 Turkey (Türkiye). 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?
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?
Mean Age at Pubertal Onset (time frame: 4 years). 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 12 Feb 2025.