PCOS Indirect and Intangible Economic Burden (PCOSCHALLENGE)

June 5, 2023 updated by: PCOS Challenge: The National Polycystic Ovary Syndrome Association

The PCOS Indirect and Intangible Economic Burden Study. A Sub-study of the PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • PCOS Challenge: The National Polycystic Ovary Syndrome Association
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information
Time Frame: One Year
Such as responses to survey questions
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PCOS Challenge: The National Polycystic Ovary Syndrome Association

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOSC002: PCOS Economic Burden

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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