Polycystic Ovary SyndromeNCT02010814
Characterization of a Prospective Cohort of Women With PCOS
An observational study of Polycystic Ovary Syndrome, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2012to 1 Jan 2028
- How long will I take part?
- 1 Day
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with PCOS, diagnosed by the Rotterdam criteria which include at least two of the following: * irregular mestrual cycle * polycystic ovaries * biochemical/clinical hyperandrogenemia
Who may be able to join
- PCOS
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Odense University Hospital
Odense, 5000
Dorte Glintborg, MD PhD, 0045 65412502, dorte.glintborg@rsyd.dk
Marianne Andersen, DMSci
About this study
Official title: Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT.
As part of the project, a Biobank with fasting blood samples from participants is established.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Inflammation, Body Composition
- Medical subject headings
- Polycystic Ovary Syndrome, Inflammation
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 |
|---|---|---|
| PCOS | Women fulfilling at least two of the three Rotterdam criteria for PCOS, including * Irregular menstrual cycle * Clinical/biochemical hyperandrogenemia * Polycystic ovaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mass density (BMD)
BMD measured by DXA scans and ExtremeCT scans.
Measured: baseline
Secondary outcomes (1)
Stress hormones
Measurement of cortisol and steroid metabolites in 24 hour urine samples
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start1 Jan 2012
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (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.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Dorte Glintborg, MD PhD, Principal investigator, Department of Endocrinology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010814
- Sponsor's protocol ID
- BIO
- Other IDs
- PCOS Biobank
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2013
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Endocrinological Characterization of a Prospective Cohort of Women With PCOS
- ClinicalTrials.gov ID
- NCT02010814
- Acronym / sponsor ID
- BIO
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Inflammation, Body Composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 Dec 2013 (estimated)
- 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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. PCOS is characterized by increase levels of testosterone, unwanted hair growth, adiposity, irregular menstrual cycle, and infertility. PCOS is associated with diabetes mellitus and cardiovascular diseases. Women with PCOS are reported to have increased levels of stress hormones, which may be associated with decreased quality of life. Increased testosterone levels in women may decrease the risk of osteoporosis. The aim of the present study is to measure levels of stress hormones in urine and describe quality of life using questionnaires. In addition we aim to characterize body composition and bone architecture using DXA and ExtremeCT.
As part of the project, a Biobank with fasting blood samples from participants is established.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | –Women fulfilling at least two of the three Rotterdam criteria for PCOS, including * Irregular menstrual cycle * Clinical/biochemical hyperandrogenemia * Polycystic ovaries |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with PCOS, diagnosed by the Rotterdam criteria which include at least two of the following: * irregular mestrual cycle * polycystic ovaries * biochemical/clinical hyperandrogenemia
Key inclusion criteria (1 listed)
- PCOS
Key exclusion criteria (1 listed)
- pregnancy
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
bone mass density (BMD)
Time frame: baseline
BMD measured by DXA scans and ExtremeCT scans.
1 secondary outcome
Stress hormones
Time frame: Baseline
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 25 Apr 2023.
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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.
Dorte Glintborg, MD PhD principal investigator
Department of Endocrinology, Odense University Hospital
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 Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 25 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 Denmark. 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 Marianne Andersen, DMSci (0045 65412502, marianne.andersen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mass density (BMD) (time frame: baseline). 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 25 Apr 2023.