The PCOS Challenge Study | NCT05797909

Studies
The PCOS Challenge Study

NCT05797909

Sponsor

PCOS Challenge: The National Polycystic Ovary Syndrome Association

Status

Recruiting

Last Update Posted

Apr 4, 2023Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2022Actual

Primary Completion Date

Jun 2042Estimated

Completion Date

Dec 31, 2042Estimated

First Submitted Date

Mar 22, 2023

First Submission Date that Met QC Criteria

Mar 22, 2023

First Posted Date

Apr 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Apr 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Information	Such as responses to survey questions	One Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Born biologically female

Minimum Age

12 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sasha Ottey, MHA, MT (ASCP)	Contact	(404) 855-7244		info@pcoschallenge.org

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PCOS Challenge: The National Polycystic Ovary Syndrome Association	Recruiting	Bethesda	Maryland	20817	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided