NCT07161440

Steroid Profiles in PCOS and Effect of OCP Treatment

Steroid Profiling in Adolescents and Young Women With PCOS: Effects of Oral Contraceptive Therapy Assessed by LC-MS/MS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: Female
• Age: 13 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome (PCOS)

Timeline

• Start date: 2021-01-02
• Primary completion: 2024-07-01
• Completion: 2025-08-04
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)