PCOS Indirect and Intangible Economic Burden
PCOSCHALLENGE
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
1 other identifier
observational
1,000
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
June 22, 2022
CompletedFirst Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 15, 2023
June 1, 2023
1.9 years
June 5, 2023
June 5, 2023
Conditions
Keywords
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
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
- Shared Documents
- STUDY PROTOCOL
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.