Spexin and Phoenixin-20 in Girls With Central Precocious Puberty

NCT07359092 | Completed

• 1 other identifier: SPX-PNX-CPP-2024
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Central Precocious Puberty (CPP); Puberty; Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder); Puberty Disorders

Keywords

Spexin; Phoenixin-20; Children; Girls; Puberty; Precocious puberty

Outcome Measures

Primary Outcomes (1)

• 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.

  At initial clinical evaluation

Study Arms (3)

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

Eligibility Criteria

• Age: 4 Years - 8 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)