- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644305
Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.
June 26, 2018 updated by: Zehra Berberoglu, Ankara Education and Research Hospital
1. Association of Plasma GDF-9 or GDF-15 Levels With Bone Parameters in Polycystic Ovary Syndrome. 2. Plasma GDF-15 Levels and Their Association With Hormonal and Metabolic Status in Women With Polycystic Ovary Syndrome Aged 25-35.
The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their association with bone and cardiovascular parameters in patients with Polycystic Ovary Syndrome.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06340
- Ankara Education and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Hospital Endocrinology Outpatient Clinic
Description
Inclusion Criteria:
- Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism
Exclusion Criteria:
- acute infectious disease, a thyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorder; history of cardiovascular disease or pulmonary embolism; a family history of coronary artery disease; smoking history; hypertension; diabetes mellitus; use of oral contraceptives, anti-androgens and drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs.
any medication known to affect hormonal or metabolic parameters.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Control
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Polycystic Ovary Syndrome
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Idiopathic hirsutism
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 19, 2012
Study Record Updates
Last Update Posted (Actual)
June 27, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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Riphah International UniversityCompleted
-
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Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPolycystic Ovary Syndrome (PCOS)United States