NCT01088061

Brief Summary

The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese women with and without PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
Last Updated

October 28, 2011

Status Verified

January 1, 2008

Enrollment Period

2.2 years

First QC Date

March 16, 2010

Last Update Submit

October 27, 2011

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Adipose expression of adipocytokines

    From February 2004 -April 2006

Secondary Outcomes (1)

  • Plasma levels of adipocytokines

    From February 2004-April 2006

Study Arms (4)

lean women with PCOS

Obese women with PCOS

lean control women

Obese control women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Lean and obese women with and without PCOS, age 18-40 years.

You may qualify if:

  • women with PCOS according to the Rotterdam criteria

You may not qualify if:

  • other known diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, Denmark, 1650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fat biopsies, plasma

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Pernille Fog Svendsen, MD

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

January 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

October 28, 2011

Record last verified: 2008-01

Locations

DK(1)