NCT07127458

Brief 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. This study aims to determine the prevalence of anxiety and depression in adolescents with PCOS and to assess changes following oral contraceptive use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

August 11, 2025

Last Update Submit

March 22, 2026

Conditions

Keywords

Polycystic Ovary Syndrome (PCOS)AdolescentsAnxiety and Depression

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Depression Inventory

    Change in Beck Depression Inventory Score After 6 Months of Oral Contraceptive Use

    6 Months

Study Arms (1)

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.

Drug: Adolescent PCOS group receiving oral contraceptives

Interventions

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.

Adolescents with Polycystic Ovary Syndrome

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 15 and 19 years
  • Diagnosis of adolescent polycystic ovary syndrome (PCOS)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

August 17, 2025

Primary Completion

March 17, 2026

Study Completion

March 17, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations