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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07161440
Acronym
PCOSLCMS
Enrollment
56
Registered
2025-09-08
Start date
2021-01-02
Completion date
2025-08-04
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

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

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.

Interventions

None listed

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum adrogen levels6 monthsChange 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 levels6 monthsChange 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

MeasureTime frameDescription
Change in serum steroid hormone levels after 6 months of OCP treatment in adolescents with PCOSBaseline and 6 months after the initiation of OCP treatmentComparison 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026