Steroid Profiles in PCOS and Effect of OCP Treatment

Completed

• Conditions: Polycystic Ovary Syndrome (PCOS)

• Registration Number: NCT07161440
• Lead Sponsor: Istanbul University

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.

Detailed Description

The study enrolled 56 female patients aged 13-21 years with a diagnosis of PCOS according to Rotterdam criteria. At baseline, all participants underwent LC-MS/MS steroid profiling. A subgroup of 15 patients received oral contraceptive therapy based on clinical indication, independent of the study protocol. A second LC-MS/MS steroid analysis was performed at 6 months in this subgroup. The primary aim was to investigate the effect of OCP on the steroid biosynthesis profile. The study was approved by the Istanbul University Ethics Committee (Approval ID: 2019/822) and conducted between January 2020 and December 2021.

Study Timeline

• Study Start: 2021-01-02
• Primary Completion: 2024-07-01
• Status Verified: 2025-08
• Study Completion: 2025-08-04
• Study First Submitted: 2025-08-30
• Study First Submitted QC: 2025-08-30
• Last Update Submitted: 2025-08-30
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum adrogen levels	6 months	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.
serum androgen levels	6 months	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.

Secondary Outcome Measures

Name	Time	Method
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	Comparison of steroid hormone profiles measured by LC-MS/MS between the baseline and 6-month follow-up in adolescent PCOS patients who were treated with oral contraceptive pills (OCP). This outcome aims to assess the impact of OCP therapy on specific androgenic and progestogenic steroid metabolites.

Trial Locations

Locations (1)

Istanbul University; Istanbul, Turkey (Türkiye)