The PCOS Challenge Study

NCT05797909 | Recruiting

• 1 other identifier: PCOSC001
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of The PCOS Challenge Study will be to conduct high-quality research where patients are included in the design, and answering the questions that patients identify as important to their lived experience with PCOS. In partnership with clinical investigators, patients will work on the development and management of data collection, the research agenda, and the sharing of research findings. The PCOSC Study will promote the advancement of research that provides reliable, useful, and meaningful information to patients with PCOS and their clinicians. The population for The PCOS Challenge Study 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.

Conditions

Polycystic Ovary Syndrome

Keywords

pcos; polycystic ovary syndrome; polycystic ovarian syndrome; stein 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

• Age: 12 Years - 80 Years
• Gender Eligibility Details: Born biologically female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for The PCOS Challenge Study 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

Sponsors & Collaborators

• PCOS Challenge: The National Polycystic Ovary Syndrome Association: lead

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 Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine 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

(404) 855-7244; info@pcoschallenge.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 1, 2042
• Study Completion (Estimated): December 31, 2042
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)