The PCOS Challenge Study

Polycystic Ovary Syndrome Clinical Trial

— PCOSCHALLENGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797909
• Other study ID #: PCOSC001
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: December 31, 2042

Study information

• Verified date: March 2023
• Source: PCOS Challenge: The National Polycystic Ovary Syndrome Association
• Contact: Sasha Ottey, MHA, MT (ASCP)
• Phone: (404) 855-7244
• Email: info[@]pcoschallenge.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2042
• Est. primary completion date: June 2042
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	PCOS Challenge: The National Polycystic Ovary Syndrome Association	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
PCOS Challenge: The National Polycystic Ovary Syndrome Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information	Such as responses to survey questions	One Year