The PCOS Challenge Study

NCT ID: NCT05797909

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-22

Study Completion Date

2042-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PCOS Challenge: The National Polycystic Ovary Syndrome Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sasha Ottey, MHA, MT (ASCP)

Role: PRINCIPAL_INVESTIGATOR

PCOS Challenge: The National Polycystic Ovary Syndrome Association

Ricardo Azziz, MD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

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PCOS Challenge: The National Polycystic Ovary Syndrome Association

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sasha Ottey, MHA, MT (ASCP)

Role: CONTACT

(404) 855-7244

Facility Contacts

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Sasha Ottey, MHA, MT (ASCP)

Role: primary

(404) 855-7244

Other Identifiers

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PCOSC001

Identifier Type: -

Identifier Source: org_study_id

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