Polycystic Ovary SyndromeNCT01644305
Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.
An observational study of Polycystic Ovary Syndrome, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Adult
Study population: Hospital Endocrinology Outpatient Clinic
Who may be able to join
- Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Education and Research Hospital
Ankara, 06340
About this study
Official title: 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.
- Conditions
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Polycystic Ovary Syndrome | Not described | |
| Idiopathic hirsutism | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zehra Berberoglu, Ankara Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644305
- Sponsor's protocol ID
- 3849
- Status last verified
- Jun 2018
- First submitted
- 17 Jul 2012
- Last updated
- 27 Jun 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24430093
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01644305
- Acronym / sponsor ID
- 3849
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polycystic Ovary Syndrome | – | – |
| Idiopathic hirsutism | – | – |
| Control | – | – |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Hospital Endocrinology Outpatient Clinic
Key inclusion criteria (1 listed)
- Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Derived from this study: PubMed 24430093Berberoglu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.