Polycystic Ovary SyndromePCOSCHALLENGENCT05797909
The PCOS Challenge Study
An observational study of Polycystic Ovary Syndrome, run by PCOS Challenge: The National Polycystic Ovary Syndrome Association at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 31 Dec 2042
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unable to understand the surveys or what is being asked
- Unwilling to sign the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PCOS Challenge: The National Polycystic Ovary Syndrome Association
Bethesda, Maryland, 20817
Sasha Ottey, MHA, MT (ASCP), (404) 855-7244, info@pcoschallenge.org
About this study
Official title: The PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients
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
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information
Such as responses to survey questions
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start22 Jun 2022
- Primary completionJun 2042 (estimated)
- Study completion31 Dec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- PCOS Challenge: The National Polycystic Ovary Syndrome Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasha Ottey, MHA, MT (ASCP), Principal investigator, PCOS Challenge: The National Polycystic Ovary Syndrome AssociationRicardo Azziz, MD, MPH, MBA, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797909
- Sponsor's protocol ID
- PCOSC001
- Acronym
- PCOSCHALLENGE
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients
- ClinicalTrials.gov ID
- NCT05797909
- Acronym / sponsor ID
- PCOSCHALLENGE / PCOSC001
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- pcos, polycystic ovary syndrome, polycystic ovarian syndrome, stein leventhal syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- PCOS Challenge: The National Polycystic Ovary Syndrome AssociationUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Jun 2042 (estimated)
- Study completion
- 31 Dec 2042 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to understand the surveys or what is being asked
- Unwilling to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Information
Time frame: One Year
Such as responses to survey questions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Ottey, MHA, MT (ASCP) principal investigator
PCOS Challenge: The National Polycystic Ovary Syndrome Association
Ricardo Azziz, MD, MPH, MBA principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by PCOS Challenge: The National Polycystic Ovary Syndrome Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sasha Ottey, MHA, MT (ASCP) ((404) 855-7244, info@pcoschallenge.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.