Steroid Profiles in PCOS and Effect of OCP Treatment

NCT07161440 | Completed

• 1 other identifier: PEDENDO-ITF-PCOS-LCMS
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study investigates the changes in serum steroid intermediates assessed by liquid chromatography-mass spectrometry (LC-MS/MS) in adolescents and young women with polycystic ovary syndrome (PCOS), before and after oral contraceptive (OCP) treatment.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS; Steroid Profiling; Oral Contraceptives; LC-MS/MS; Adolescents; Hyperandrogenism

Outcome Measures

Primary Outcomes (2)

• Serum adrogen levels

  Change in serum androgen levels (e.g., testosterone, androstenedione, DHEAS) measured by LC-MS/MS between baseline and 6 months in the OCP-treated group.

  6 months

• serum androgen levels

  Change in serum androgen levels (e.g., testosterone, androstenedione, DHEAS) measured by LC-MS/MS between baseline and 6 months in the OCP-treated group.

  6 months

Secondary Outcomes (1)

• Change in serum steroid hormone levels after 6 months of OCP treatment in adolescents with PCOS

  Baseline and 6 months after the initiation of OCP treatment

Study Arms (2)

PCOS patients without treatment

This cohort included adolescent patients diagnosed with polycystic ovary syndrome (PCOS) who did not receive any medical treatment during the study period. Steroid hormone levels were measured using LC-MS/MS at baseline for all participants to evaluate the endogenous steroid profile in untreated PCOS.

PCOS patients treated with OCP

This cohort consisted of adolescent patients with polycystic ovary syndrome (PCOS) who were prescribed oral contraceptive pills (OCP) due to clinical indications. A total of 15 patients from the untreated PCOS group received OCP treatment and were followed for 6 months. Baseline and 6-month serum samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to evaluate changes in steroid hormone profiles after treatment.

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent females aged 13 to 21 years diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. All participants were evaluated at the Istanbul Faculty of Medicine between 2020 and 2021. Baseline serum steroid profiles were analyzed using LC-MS/MS in all participants. A subset of 15 patients received oral contraceptive treatment for medical indications and had follow-up hormonal evaluations at 6 months.

You may qualify if:

• Diagnosis of PCOS based on Rotterdam criteria
• Age between 13 and 21 years
• No hormonal treatment in the 3 months prior to study enrollment
• Consent provided

You may not qualify if:

• Congenital adrenal hyperplasia
• Cushing's syndrome
• Pregnancy
• Use of hormonal medications within 1 year prior to baseline

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were retained for analysis. These samples were used to assess the steroid profile via liquid chromatography-mass spectrometry (LC-MS/MS). Specifically, levels of intermediate steroid metabolites such as 17-hydroxyprogesterone, androstenedione, testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), 11-deoxycortisol, and cortisol were evaluated.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Melek Yildiz, Associate Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: January 2, 2021
• Primary Completion: July 1, 2024
• Study Completion: August 4, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)