Central Precocious Puberty (CPP)SPX-PNX-CPP-20NCT07359092
Spexin and Phoenixin-20 in Girls With Central Precocious Puberty
An observational study of Central Precocious Puberty (CPP) and Puberty Disorders, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Central precocious puberty (CPP) is characterized by the early activation of the hypothalamic-pituitary-gonadal axis in girls and may be difficult to distinguish from benign variants such as premature thelarche. Read more about this study
- Who is it for?
- Ages 4 to 8 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Central Precocious Puberty (CPP), Puberty Disorders, Puberty
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jan 2026
- 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 4 to 8 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Girls younger than 8 years who presented for evaluation of early pubertal signs between December 2024 and December 2025. Participants were classified into two groups: CPP and PT; according to LH-RH stimulation test peak LH levels. And a third group was included (totally three groups) for age matched healthy controls.
Who may be able to join
- Female sex
- Age younger than 8 years,
- Presentation for evaluation of early pubertal signs (breast development)
- Classification into one of the following groups: central precocious puberty, premature thelarche, or healthy control
Who cannot join
- Presence of peripheral precocious puberty,
- Known chronic systemic disease,
- Use of medications affecting the hypothalamic-pituitary-gonadal axis,
- Known genetic syndromes of congenital endocrine disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Spexin and Phoenixin-20 Levels in Girls With Central Precocious Puberty, Premature Thelarche, and Healthy Controls
Central precocious puberty (CPP) is characterized by the early activation of the hypothalamic-pituitary-gonadal axis in girls and may be difficult to distinguish from benign variants such as premature thelarche. Spexin and phoenixin-20 are novel neuropeptides that have been suggested to play roles in reproductive axis regulation.
The aim of this study was to compare serum spexin and phoenixin-20 levels among girls with central precocious puberty, girls with premature thelarche, and healthy age-matched controls. The study evaluated whether these biomarkers could help differentiate CPP from other conditions presenting with early breast development.
Clinical, anthropometric, and biochemical parameters were analyzed in all participants. Blood samples were collected and serum spexin and phoenixin-20 levels were measured using commercially available assay kits.
Read the detailed description
This was a prospective, observational study conducted in a pediatric endocrinology outpatient clinic. The study population consisted of girls younger than 8 years of age who presented between December 2024 and December 2025. Participants were categorized into three groups: girls diagnosed with central precocious puberty (CPP), girls with premature thelarche (PT), and healthy age-matched control subjects. The CPP group: 33 patients, PT group: 57 patients, and healthy controls: 53 patients.
The diagnosis of central precocious puberty was based on clinical findings, auxological data, bone age assessment, and hormonal evaluation according to standard pediatric endocrinology criteria. Premature thelarche was defined as isolated breast development without other signs of pubertal progression or activation of the hypothalamic-pituitary-gonadal axis.
Clinical and anthropometric data, including age, height, weight, body mass index, bone age, were recorded. Blood samples were obtained under standardized conditions, and also LH-RH stimulation test was applied in CPP and PT groups. Basal and stimulated FSH and LH hormone levels were examined. In addition, serum spexin and phoenixin-20 concentrations were measured using enzyme-linked immunosorbent assay kits in accordance with the manufacturers' instructions.
The primary objective of the study was to investigate whether serum spexin and phoenixin-20 levels differ between girls with CPP and those with PT or healthy controls, and whether these biomarkers could aid in distinguishing CPP from other causes of early pubertal signs.
- Conditions
- Central Precocious Puberty (CPP), Puberty Disorders, Puberty, Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
- Keywords
- Spexin, Phoenixin-20, Children, Girls, Puberty, Precocious puberty
- Medical subject headings
- Puberty, Precocious
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 |
|---|---|---|
| Central Precocious Puberty (CPP) | Girls younger than 8 years diagnosed with CPP based on clinical findings (breast development stage) and LH-RH stimulation test peak LH level >5 mIU/mL | |
| Premature Thelarche (PT) | Girls younger than 8 years presenting with isolated breast development and LH-RH stimulation test peak LH level <5 mIU/mL | |
| Healthy controls | Age-matched healthy girls without signs of breast development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Spexin and Phoenixin-20 levels
Comparison of serum Spexin and Phoenixin-20 concentrations among girls with central precocious puberty, premature thelarche, and healthy controls.
Measured: At initial clinical evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Precocious Puberty (CPP)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Bilge Koca, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359092
- Sponsor's protocol ID
- SPX-PNX-CPP-2024
- Acronym
- SPX-PNX-CPP-20
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared from this study
Publications
Koca SB, Kirkgoz T, Kara L, Gok E, Kocer D, Demirbilek H. The role of Spexin and Phoenixin-20 in girls during puberty. BMC Endocr Disord. 2026 Apr 11;26(1):148. doi: 10.1186/s12902-026-02268-0.
PubMed 41965607
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spexin and Phoenixin-20 Levels in Girls With Central Precocious Puberty, Premature Thelarche, and Healthy Controls
- ClinicalTrials.gov ID
- NCT07359092
- Acronym / sponsor ID
- SPX-PNX-CPP-20 / SPX-PNX-CPP-2024
- Conditions
- Central Precocious Puberty (CPP), Puberty Disorders, Puberty, Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
- Keywords
- Spexin, Phoenixin-20, Children, Girls, Puberty, Precocious puberty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 22 Jan 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.
Central precocious puberty (CPP) is characterized by the early activation of the hypothalamic-pituitary-gonadal axis in girls and may be difficult to distinguish from benign variants such as premature thelarche. Spexin and phoenixin-20 are novel neuropeptides that have been suggested to play roles in reproductive axis regulation.
The aim of this study was to compare serum spexin and phoenixin-20 levels among girls with central precocious puberty, girls with premature thelarche, and healthy age-matched controls. The study evaluated whether these biomarkers could help differentiate CPP from other conditions presenting with early breast development.
Clinical, anthropometric, and biochemical parameters were analyzed in all participants. Blood samples were collected and serum spexin and phoenixin-20 levels were measured using commercially available assay kits.
Detailed description
This was a prospective, observational study conducted in a pediatric endocrinology outpatient clinic. The study population consisted of girls younger than 8 years of age who presented between December 2024 and December 2025. Participants were categorized into three groups: girls diagnosed with central precocious puberty (CPP), girls with premature thelarche (PT), and healthy age-matched control subjects. The CPP group: 33 patients, PT group: 57 patients, and healthy controls: 53 patients.
The diagnosis of central precocious puberty was based on clinical findings, auxological data, bone age assessment, and hormonal evaluation according to standard pediatric endocrinology criteria. Premature thelarche was defined as isolated breast development without other signs of pubertal progression or activation of the hypothalamic-pituitary-gonadal axis.
Clinical and anthropometric data, including age, height, weight, body mass index, bone age, were recorded. Blood samples were obtained under standardized conditions, and also LH-RH stimulation test was applied in CPP and PT groups. Basal and stimulated FSH and LH hormone levels were examined. In addition, serum spexin and phoenixin-20 concentrations were measured using enzyme-linked immunosorbent assay kits in accordance with the manufacturers' instructions.
The primary objective of the study was to investigate whether serum spexin and phoenixin-20 levels differ between girls with CPP and those with PT or healthy controls, and whether these biomarkers could aid in distinguishing CPP from other causes of early pubertal signs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Central Precocious Puberty (CPP) | – | –Girls younger than 8 years diagnosed with CPP based on clinical findings (breast development stage) and LH-RH stimulation test peak LH level >5 mIU/mL |
| Premature Thelarche (PT) | – | –Girls younger than 8 years presenting with isolated breast development and LH-RH stimulation test peak LH level <5 mIU/mL |
| Healthy controls | – | –Age-matched healthy girls without signs of breast development |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Girls younger than 8 years who presented for evaluation of early pubertal signs between December 2024 and December 2025. Participants were classified into two groups: CPP and PT; according to LH-RH stimulation test peak LH levels. And a third group was included (totally three groups) for age matched healthy controls.
Key inclusion criteria (4 listed)
- Female sex
- Age younger than 8 years,
- Presentation for evaluation of early pubertal signs (breast development)
- Classification into one of the following groups: central precocious puberty, premature thelarche, or healthy control
Key exclusion criteria (4 listed)
- Presence of peripheral precocious puberty,
- Known chronic systemic disease,
- Use of medications affecting the hypothalamic-pituitary-gonadal axis,
- Known genetic syndromes of congenital endocrine disorders
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
Serum Spexin and Phoenixin-20 levels
Time frame: At initial clinical evaluation
Comparison of serum Spexin and Phoenixin-20 concentrations among girls with central precocious puberty, premature thelarche, and healthy controls.
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 22 Jan 2026.
- Derived from this study: PubMed 41965607Koca SB, Kirkgoz T, Kara L, Gok E, Kocer D, Demirbilek H. The role of Spexin and Phoenixin-20 in girls during puberty. BMC Endocr Disord. 2026 Apr 11;26(1):148. doi: 10.1186/s12902-026-02268-0.
- Individual participant dataSharing planned: No. No individual participant data will be shared from this study
Related trials for Central Precocious Puberty (CPP)
Active, not recruitingPhase 4
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
CPP
RecruitingObservational study
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Central Precocious Puberty (CPP)
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 Central Precocious Puberty (CPP) and Puberty Disorders, run by Kayseri City 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 4 inclusion and 4 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 22 Jan 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 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?
Serum Spexin and Phoenixin-20 levels (time frame: At initial clinical evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07359092, which also lists 1 linked publication.
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 22 Jan 2026.