NCT01644305

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

July 17, 2012

Last Update Submit

June 26, 2018

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome

    1 year

Study Arms (3)

Polycystic Ovary Syndrome

Idiopathic hirsutism

Control

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Hospital Endocrinology Outpatient Clinic

You may qualify if:

  • Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Education and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (1)

  • Berberoglu Z, Aktas A, Fidan Y, Yazici AC, Aral Y. Association of plasma GDF-9 or GDF-15 levels with bone parameters in polycystic ovary syndrome. J Bone Miner Metab. 2015 Jan;33(1):101-8. doi: 10.1007/s00774-013-0560-8. Epub 2014 Jan 16.

    PMID: 24430093DERIVED

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

TU(1)