Characterization of a Prospective Cohort of Women With PCOS

NCT ID: NCT02010814

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2028-01-01

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PCOS

Women fulfilling at least two of the three Rotterdam criteria for PCOS, including

* Irregular menstrual cycle
* Clinical/biochemical hyperandrogenemia
* Polycystic ovaries

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* PCOS

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Andersen

DMSci

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorte Glintborg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Odense University Hospital

Locations

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Department of Endocrinology, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Marianne Andersen, DMSci

Role: CONTACT

0045 65412502

Facility Contacts

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Dorte Glintborg, MD PhD

Role: primary

0045 65412502

Other Identifiers

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PCOS Biobank

Identifier Type: REGISTRY

Identifier Source: secondary_id

BIO

Identifier Type: -

Identifier Source: org_study_id

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