Women With Polycystic Ovary Syndrome (PCOS) | NCT02467751

Studies
Women With Polycystic Ovary Syndrome (PCOS)

NCT02467751

Sponsor

Irmandade da Santa Casa de Misericordia de Sao Paulo

Status

Unknown status

Last Update Posted

Mar 20, 2017Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Brazil

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Sep 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Jun 7, 2015

First Posted Date

Jun 10, 2015Estimated

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 17, 2017

Last Update Posted Date

Mar 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carolina Furtado Macruz, Doctor, Irmandade da Santa Casa de Misericordia de Sao PauloPrincipal Investigator

Lead Sponsor

Irmandade da Santa Casa de Misericordia de Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolic profile	total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate	12 months

Secondary Outcomes

Measure	Description	Time Frame
Classical glycemic index	Classical glycemic index (mg/dL) will estimate	12 months
Liver function	Liver function (U/L) will estimate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

39 Years

Standard Ages

ChildAdult

Study Population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carolina F Macruz, doctor	Contact	+5511999141447	Brazil	carolmacruz@gmail.com
Irmandade Santa Casa Sao Paulo	Contact	+551121767385	Brazil

Overall Officials

Name	Affiliation	Role
Carolina Macruz	Irmandade Santa Casa de Misericordia Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carolina Furtado Macruz	Recruiting	São Paulo	São Paulo	01225001	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37909624	Derived	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.
28099715	Derived	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.

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