NCT05903404

Brief Summary

The primary purpose of the PCOS Indirect and Intangible Economic Buren study is to estimate the economic costs of having PCOS in terms of quality of life and work productivity. The population will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS. This study is a sub-study of The PCOS Challenge Study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 22, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

June 5, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

pcospolycystic ovary syndromepolycystic ovarian syndromestein leventhal syndrome

Outcome Measures

Primary Outcomes (1)

  • Information

    Such as responses to survey questions

    One Year

Study Arms (2)

Target Population

The target population includes individuals diagnosed with PCOS by a healthcare provider, self-diagnosed with PCOS, or who are exhibiting PCOS Symptoms and willing to sign the consent.

Control Population

The control population includes people born biologically female who have not been diagnosed with PCOS and who also do not have symptoms of PCOS.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBorn biologically female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population for the PCOS Indirect and Intangible Economic Burden will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.

You may qualify if:

  • Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms
  • Willing to sign the consent form
  • Able to understand the registry surveys or what is being asked

You may not qualify if:

  • Unable to understand the surveys or what is being asked
  • Unwilling to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PCOS Challenge: The National Polycystic Ovary Syndrome Association

Bethesda, Maryland, 20817, United States

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 Officials

  • Sasha Ottey, MHA, MT (ASCP)

    PCOS Challenge: The National Polycystic Ovary Syndrome Association

    PRINCIPAL INVESTIGATOR
  • Ricardo Azziz, MD, MPH, MBA

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sasha Ottey, MHA, MT (ASCP)

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 15, 2023

Study Start

June 22, 2022

Primary Completion

June 1, 2024

Study Completion

December 31, 2024

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in PCOS. Data or samples shared will be coded, with no PHI included.

Shared Documents
STUDY PROTOCOL

Locations