Polycystic Ovary SyndromeNCT01538602
Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Adult
Study population: Volunteers
Who may be able to join
- Women fulfilled two out of three diagnostic criteria for PCOS
Who cannot join
- Pre-existing secondary endocrine disorders
- History of hypertension, diabetes mellitus or cardiovascular disorders
- Pharmacologic treatment in the last 6 months before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, cardiovascular disorders
- Medical subject headings
- Polycystic Ovary Syndrome, Cardiovascular Diseases
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 patients | Not described | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean platelet volume
Thromboxane A2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (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
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538602
- Sponsor's protocol ID
- MPV_PCOS
- Status last verified
- Feb 2012
- First submitted
- 21 Feb 2012
- Last updated
- 24 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT01538602
- Acronym / sponsor ID
- MPV_PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, cardiovascular disorders
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 24 Feb 2012 (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 closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS patients | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Volunteers
Key inclusion criteria (1 listed)
- Women fulfilled two out of three diagnostic criteria for PCOS
Key exclusion criteria (3 listed)
- Pre-existing secondary endocrine disorders
- History of hypertension, diabetes mellitus or cardiovascular disorders
- Pharmacologic treatment in the last 6 months before entering the study.
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
Mean platelet volume
Thromboxane A2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 24 Feb 2012. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean platelet volume. The study lists 2 primary outcomes in all. 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 24 Feb 2012.