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Polycystic Ovary SyndromePCOSNCT02467751

Women With Polycystic Ovary Syndrome (PCOS)

An observational study of Polycystic Ovary Syndrome, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Metabolic profile in women of different body composition with polycystic ovary syndrome. Read more about this study

Who is it for?
Ages 12 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
How many people
90 participants
Where
1 siteBrazil
Study dates
Jan 2014to Dec 2017
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 12 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities.

Who may be able to join

  • Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.

Who cannot join

  • Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL)
  • Cushing's syndrome
  • Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal
  • Antidiabetic and antiobesity drugs.

Trial locations and contacts

1 site in 1 country.

Carolina F Macruz, doctor contact

+5511999141447 ext. Brazil

carolmacruz@gmail.com

Irmandade Santa Casa Sao Paulo contact

+551121767385 ext. Brazil

Brazil1 site, 1 recruiting

  • Carolina Furtado Macruz

    São Paulo, São Paulo, 01225001

    Carolina Macruz, +5511999141447, carolmacruz@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome

Metabolic profile in women of different body composition with polycystic ovary syndrome.

Read the detailed description

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.

Medical subject headings
Polycystic Ovary Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic profile

    total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate

    Measured: 12 months

Secondary outcomes (11)

  1. Classical glycemic index

    Classical glycemic index (mg/dL) will estimate

    Measured: 12 months

  2. Liver function

    Liver function (U/L) will estimate

    Measured: 12 months

  3. luteinizing hormone

    luteinizing hormone (IU/L) will estimate

    Measured: 12 months

  4. Hormonal profile - insulin

    Hormonal profile - insulin (uIU/ml) will estimate

    Measured: 12 months

  5. Follicle stimulating hormone

    Follicle stimulating hormone (IU/L) will estimate

    Measured: 12 months

  6. thyreostimulating hormone

    thyreostimulating hormone (uIU/ML) will estimate

    Measured: 12 months

  7. Total and free testosterone

    Total and free testosterone (ng/ml) will estimate

    Measured: 12 months

  8. 17-hydroxyprogesterone

    17-hydroxyprogesterone (ng/ml) will estimate

    Measured: 12 months

  9. Dehydroepiandrosterone

    Dehydroepiandrosterone (ng/ml) will estimate

    Measured: 12 months

  10. Prolactin

    Prolactin (ug/ml) will estimate

    Measured: 12 months

  11. DEXA

    Body composition will measure by DEXA scan

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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 crossover
Time perspective
Cross-sectional
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467751
Sponsor's protocol ID
167/10
Acronym
PCOS
Status last verified
Mar 2017
First submitted
25 Mar 2015
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: When I have finished my recruitment and analysis of the results.

Publications

  • Macruz CF, Lima SMRR. Polycystic ovary syndrome and abdominal fat: is there a relationship? Rev Assoc Med Bras (1992). 2023 Oct 27;69(11):e20230874. doi: 10.1590/1806-9282.20230874. eCollection 2023.

    PubMed 37909624

  • Macruz CF, Lima SM, Salles JE, da Silva GM, Scalissi NM. Assessment of the body composition of patients with polycystic ovary syndrome using dual-energy X-ray absorptiometry. Int J Gynaecol Obstet. 2017 Mar;136(3):285-289. doi: 10.1002/ijgo.12066. Epub 2017 Jan 6.

    PubMed 28099715

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.

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 4 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: status not confirmed, as of the sponsor's last update on 20 Mar 2017. 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 Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carolina F Macruz, doctor (+5511999141447 ext. Brazil, carolmacruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic profile (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02467751, which also lists 2 linked publications.

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 20 Mar 2017.

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