PCOS (Polycystic Ovary Syndrome)NCT07127458
Anxiety and Depression in Adolescent PCOS
A study testing Adolescent PCOS group receiving oral contraceptives in people with PCOS (Polycystic Ovary Syndrome), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in adolescent females, often accompanied by psychological symptoms such as anxiety and depression. These conditions are frequently underdiagnosed and untreated. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Adolescent PCOS group receiving oral contraceptives
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2025to 17 Mar 2026
- Phase
- Interventional
- 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 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 19 years
- Diagnosis of adolescent polycystic ovary syndrome (PCOS)
Who cannot join
- Severe reading or comprehension difficulties
- Severe hearing impairment
- Current use of hormone therapy
- Presence of a virilizing tumor
- Major psychiatric disorders such as schizophrenia, bipolar disorder, or dissociative disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Anxiety and Depression in Adolescents With Polycystic Ovary Syndrome
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in adolescent females, often accompanied by psychological symptoms such as anxiety and depression. These conditions are frequently underdiagnosed and untreated. This study aims to determine the prevalence of anxiety and depression in adolescents with PCOS and to assess changes following oral contraceptive use.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age, characterized by heterogeneous complications. It is increasingly prevalent among adolescent females today. Women with PCOS may experience infrequent or prolonged menstrual periods, excessive hair growth, acne, and obesity. The rising prevalence of PCOS in the general population affects approximately 5-10% of women of reproductive age worldwide (1). A significant proportion of women with PCOS-particularly adolescent girls-experience major depressive disorder. Although the exact cause of PCOS remains unknown, early diagnosis and treatment, along with weight loss, can reduce the risk of long-term complications. Depression and anxiety are common in women with PCOS; however, their frequency has often been overlooked, leaving many cases untreated (2). In addition to physical symptoms, various mental health problems are also associated with PCOS (3). The diagnosis of PCOS is established when at least two of the following criteria are present: amenorrhea/oligomenorrhea, hyperandrogenism (clinical or biochemical), and a polycystic ovarian appearance on ultrasound (4). Psychosocial problems are particularly common among obese adolescents and those with excessive hair growth.
The rationale of this study is to investigate the prevalence of this often-overlooked comorbidity and to evaluate changes following OCS (oral contraceptive) use.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Adolescent PCOS group receiving oral contraceptives
- Keywords
- Polycystic Ovary Syndrome (PCOS), Adolescents, Anxiety and Depression
- Medical subject headings
- Polycystic Ovary Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent PCOS group receiving oral contraceptivesDrug
Participants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once daily for six consecutive months. The intervention aims to regulate menstrual cycles, reduce hyperandrogenic symptoms, and evaluate changes in anxiety and depression scores over time.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with Polycystic Ovary Syndrome | Experimental | Adolescent patients with PCOS will be identified, and the prevalence of anxiety and depression will be assessed. Oral contraceptive therapy will be initiated, and patients will be re-evaluated after 6 months. Receives: Drug: Adolescent PCOS group receiving oral contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory
Change in Beck Depression Inventory Score After 6 Months of Oral Contraceptive Use
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start17 Aug 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Ege 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127458
- Sponsor's protocol ID
- A-PCOS-1
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anxiety and Depression in Adolescents With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07127458
- Acronym / sponsor ID
- A-PCOS-1
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- Polycystic Ovary Syndrome (PCOS), Adolescents, Anxiety and Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 17 Aug 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.
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder in adolescent females, often accompanied by psychological symptoms such as anxiety and depression. These conditions are frequently underdiagnosed and untreated. This study aims to determine the prevalence of anxiety and depression in adolescents with PCOS and to assess changes following oral contraceptive use.
Detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age, characterized by heterogeneous complications. It is increasingly prevalent among adolescent females today. Women with PCOS may experience infrequent or prolonged menstrual periods, excessive hair growth, acne, and obesity. The rising prevalence of PCOS in the general population affects approximately 5-10% of women of reproductive age worldwide (1). A significant proportion of women with PCOS-particularly adolescent girls-experience major depressive disorder. Although the exact cause of PCOS remains unknown, early diagnosis and treatment, along with weight loss, can reduce the risk of long-term complications. Depression and anxiety are common in women with PCOS; however, their frequency has often been overlooked, leaving many cases untreated (2). In addition to physical symptoms, various mental health problems are also associated with PCOS (3). The diagnosis of PCOS is established when at least two of the following criteria are present: amenorrhea/oligomenorrhea, hyperandrogenism (clinical or biochemical), and a polycystic ovarian appearance on ultrasound (4). Psychosocial problems are particularly common among obese adolescents and those with excessive hair growth.
The rationale of this study is to investigate the prevalence of this often-overlooked comorbidity and to evaluate changes following OCS (oral contraceptive) use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Polycystic Ovary Syndrome | Experimental | Drug: Adolescent PCOS group receiving oral contraceptivesAdolescent patients with PCOS will be identified, and the prevalence of anxiety and depression will be assessed. Oral contraceptive therapy will be initiated, and patients will be re-evaluated after 6 months. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 15 and 19 years
- Diagnosis of adolescent polycystic ovary syndrome (PCOS)
Key exclusion criteria (5 listed)
- Severe reading or comprehension difficulties
- Severe hearing impairment
- Current use of hormone therapy
- Presence of a virilizing tumor
- Major psychiatric disorders such as schizophrenia, bipolar disorder, or dissociative disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent PCOS group receiving oral contraceptivesParticipants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once daily for six consecutive months. The intervention aims to regulate menstrual cycles, reduce hyperandrogenic symptoms, and evaluate changes in anxiety and depression scores over time. | Drug | Adolescents with Polycystic Ovary Syndrome |
Primary outcome
Change in Beck Depression Inventory
Time frame: 6 Months
Change in Beck Depression Inventory Score After 6 Months of Oral Contraceptive Use
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 25 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for PCOS (Polycystic Ovary Syndrome)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent PCOS group receiving oral contraceptives in people with PCOS (Polycystic Ovary Syndrome), run by Ege 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 2 inclusion and 5 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 25 Mar 2026. 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?
Change in Beck Depression Inventory (time frame: 6 Months). 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 25 Mar 2026.