Characterization of a Prospective Cohort of Women With PCOS | NCT02010814

Studies
Characterization of a Prospective Cohort of Women With PCOS

NCT02010814

Sponsor

Odense University Hospital

Status

Recruiting

Last Update Posted

Apr 25, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Denmark

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

ID	Type	Description	Link
PCOS Biobank	Registry Identifier	PCOS Biobank

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2028Estimated

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Dec 9, 2013

First Posted Date

Dec 13, 2013Estimated

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

Apr 24, 2023

Last Update Posted Date

Apr 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCOS		Women fulfilling at least two of the three Rotterdam criteria for PCOS, including Irregular menstrual cycle Clinical/biochemical hyperandrogenemia Polycystic ovaries

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone mass density (BMD)	BMD measured by DXA scans and ExtremeCT scans.	baseline

Secondary Outcomes

Measure	Description	Time Frame
Stress hormones	Measurement of cortisol and steroid metabolites in 24 hour urine samples	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCOS

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianne Andersen, DMSci	Contact	0045 65412502		marianne.andersen@rsyd.dk

Overall Officials

Name	Affiliation	Role
Dorte Glintborg, MD PhD	Department of Endocrinology, Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Odense University Hospital	Recruiting	Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D007249	Inflammation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided