An observational study in Polycystic Ovary Syndrome (PCOS), sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Istanbul University · Observational
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.
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 56 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
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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.
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Exclusion Criteria:
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.
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.
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.
Time frame: 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.
Time frame: 6 months
Change in serum steroid hormone levels after 6 months of OCP treatment in adolescents with PCOS
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.
Time frame: Baseline and 6 months after the initiation of OCP treatment
Plan to share: No
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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