Database Study on Patients With PCOS | NCT01338519

Studies
Database Study on Patients With PCOS

NCT01338519

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Apr 19, 2011Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Hirsutism
PCOS

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

Status Module

Record Verification Date

Jan 1997

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 1997

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Apr 18, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

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 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

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

All newly referred patients with PCOS and hirsutism are listed in a database.

Detailed Description

All premenopausal women referred to the outpatient clinic at the Department of Endocrinology from 1997 and onward with the referral diagnoses hirsutism and/or PCOS are included in a clinical database. The patients should fulfill the Rotterdam criteria for PCOS or have clinical/biochemical hyperandrogenemia.

Routine evaluation include medical history, clinical examination, transvaginal ultrasound (US), and fasting blood samples. Cycle history is recorded in all patients using a standard scheme prepared for hirsute patients. Blood tests include androgens, LH, FSH, prolactin, and lipid profile.

OGTT and ACTH are performed in high risk patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

2,000Estimated

Label	Type	Description	Intervention Names
PCOS and hirsutism

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

premenopausal
hirsutism or PCOS

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Premenopausal women referred with hirsutism or PCOS to Odense University hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dorte Glintborg, MD, PhD	Contact			dorte.glintborg@ouh.regionsyddanmark.dk

Overall Officials

Name	Affiliation	Role
Marianne Andersen, MD, PhD	Odense Univeristy Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense		DK-5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006628	Hirsutism

Ancestor Terms

ID	Term
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D014770	Virilism

Browse Leaves

Not provided

Browse Branches

Not provided