NCT05734287

Brief Summary

This mixed cohort study will test the frequency of PCOS among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. Diagnosis will be based on the recent PCOS clinical, biochemical and biophysical criteria recently published " International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) 2018".

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

February 6, 2023

Last Update Submit

July 22, 2024

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Outcome Measures

Primary Outcomes (1)

  • The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study

    7 months

Interventions

clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenismDIAGNOSTIC_TEST

To assess clinical, biophysical and biochemical criteria of young females with clinical hyperandrogenism as a search for PCOS

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Females with clinical hyperandrogenism.

You may qualify if:

  • Clinical hyperandrogenism

You may not qualify if:

  • Age less than 15 or more than 35 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atif Dervis

Doha, Qatar

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 17, 2023

Study Start

June 28, 2024

Primary Completion

July 15, 2025

Study Completion

August 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Protocol

Shared Documents
STUDY PROTOCOL
Time Frame
3 months

Locations

QA(1)