Polycystic Ovary Syndrome (PCOS)PCOSLCMSNCT07161440
Steroid Profiles in PCOS and Effect of OCP Treatment
An observational study of Polycystic Ovary Syndrome (PCOS), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2021to 4 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Congenital adrenal hyperplasia
- Cushing's syndrome
- Pregnancy
- Use of hormonal medications within 1 year prior to baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Steroid Profiling in Adolescents and Young Women With PCOS: Effects of Oral Contraceptive Therapy Assessed by LC-MS/MS
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.
Read the 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)
- Keywords
- PCOS, Steroid Profiling, Oral Contraceptives, LC-MS/MS, Adolescents, Hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCOS patients without treatment | 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. | |
| PCOS patients treated with OCP | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: Baseline and 6 months after the initiation of OCP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Jan 2021
- Primary completion1 Jul 2024
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Bayrak Demirel, Istanbul University
- Investigators
- Melek Yildiz, Associate Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161440
- Sponsor's protocol ID
- PEDENDO-ITF-PCOS-LCMS
- Acronym
- PCOSLCMS
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Profiling in Adolescents and Young Women With PCOS: Effects of Oral Contraceptive Therapy Assessed by LC-MS/MS
- ClinicalTrials.gov ID
- NCT07161440
- Acronym / sponsor ID
- PCOSLCMS / PEDENDO-ITF-PCOS-LCMS
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, Steroid Profiling, Oral Contraceptives, LC-MS/MS, Adolescents, Hyperandrogenism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS patients without treatment | – | –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. |
| PCOS patients treated with OCP | – | –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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Congenital adrenal hyperplasia
- Cushing's syndrome
- Pregnancy
- Use of hormonal medications within 1 year prior to baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melek Yildiz, Associate Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum adrogen levels (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.