Clinical trial · Observational
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
NCT07161440CI-TRIAL-00094694PCOSLCMScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- PCOS patients without treatment
- description
- 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.
- label
- PCOS patients treated with OCP
- description
- 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.
Primary outcomes (2)
- measure
- Serum adrogen levels
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.