Steroid Profiles in PCOS and Effect of OCP Treatment

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.

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Key information

Conditions

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

Age range

13 year–21 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Serum adrogen levels

Time frame: 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

Time frame: 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 outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Acronym: PCOSLCMS

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Sep 8, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed