PCOSCHALLENGE: The PCOS Challenge Study

Sponsor

PCOS Challenge: The National Polycystic Ovary Syndrome Association (Other)

Overall Status

Recruiting

CT.gov ID

NCT05797909

Collaborator

(none)

15,000

Enrollment

Location

246.3

Anticipated Duration (Months)

60.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

15000 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

The PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients

Actual Study Start Date :

Jun 22, 2022

Anticipated Primary Completion Date :

Jun 1, 2042

Anticipated Study Completion Date :

Dec 31, 2042

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Information [One Year]
Such as responses to survey questions

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PCOS Challenge: The National Polycystic Ovary Syndrome Association	Bethesda	Maryland	United States	20817

Sponsors and Collaborators

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