Polycystic Ovary SyndromePhase 4NCT00428311
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
A Phase 4 study testing Metformin and Ethynyl-estradiol plus cyproterone acetate in people with Polycystic Ovary Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and Ethynyl-estradiol plus cyproterone acetate
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2004to Oct 2006
- Phase
- Phase 4
- 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 12 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women of fertile age presenting with PCOS
- Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)
Who cannot join
- Severe disease not related to the condition under study
- Pregnancy
- Medical or surgical treatment of PCOS during the previous 3 months
- Contraindication for the use of oral contraceptives or metformin
- Inability to understand the proposal of the study precluding effective informed consent
- Minors who are not accompanied by their legal representative
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Endocrinology, Hospital Ramón y Cajal
Madrid, Madrid, E-28034
About this study
Official title: The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.
The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Ethynyl-estradiol plus cyproterone acetate
- Keywords
- Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Ethynyl-estradiol plus cyproterone acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum androgen levels
Lipid profiles
Blood pressure
Cardiovascular performance
Non-classic cardiovascular risk markers
Indexes of insulin secretion and sensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startApr 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Investigators
- Héctor F Escobar-Morreale, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428311
- Sponsor's protocol ID
- ENDOPCOS 01/2003
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 31 Jan 2007
- Results posted
- No
Publications
Luque-Ramirez M, Escobar-Morreale HF. Treatment of polycystic ovary syndrome (PCOS) with metformin ameliorates insulin resistance in parallel with the decrease of serum interleukin-6 concentrations. Horm Metab Res. 2010 Oct;42(11):815-20. doi: 10.1055/s-0030-1262855. Epub 2010 Aug 20.
PubMed 20730705Luque-Ramirez M, Alvarez-Blasco F, Escobar-Morreale HF. Antiandrogenic contraceptives increase serum adiponectin in obese polycystic ovary syndrome patients. Obesity (Silver Spring). 2009 Jan;17(1):3-9. doi: 10.1038/oby.2008.491. Epub 2008 Nov 6.
PubMed 18997670Luque-Ramirez M, Alvarez-Blasco F, Uriol Rivera MG, Escobar-Morreale HF. Serum uric acid concentration as non-classic cardiovascular risk factor in women with polycystic ovary syndrome: effect of treatment with ethinyl-estradiol plus cyproterone acetate versus metformin. Hum Reprod. 2008 Jul;23(7):1594-601. doi: 10.1093/humrep/den095. Epub 2008 Mar 27.
PubMed 18375410Luque-Ramirez M, Alvarez-Blasco F, Botella-Carretero JI, Sanchon R, San Millan JL, Escobar-Morreale HF. Increased body iron stores of obese women with polycystic ovary syndrome are a consequence of insulin resistance and hyperinsulinism and are not a result of reduced menstrual losses. Diabetes Care. 2007 Sep;30(9):2309-13. doi: 10.2337/dc07-0642. Epub 2007 May 29.
PubMed 17536071
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
- ClinicalTrials.gov ID
- NCT00428311
- Acronym / sponsor ID
- ENDOPCOS 01/2003
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2006
- First posted
- 30 Jan 2007 (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.
Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.
The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women of fertile age presenting with PCOS
- Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)
Key exclusion criteria (6 listed)
- Severe disease not related to the condition under study
- Pregnancy
- Medical or surgical treatment of PCOS during the previous 3 months
- Contraindication for the use of oral contraceptives or metformin
- Inability to understand the proposal of the study precluding effective informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | – |
| Ethynyl-estradiol plus cyproterone acetate | Drug | – |
Primary outcome
Serum androgen levels
Lipid profiles
Blood pressure
Cardiovascular performance
Non-classic cardiovascular risk markers
Indexes of insulin secretion and sensitivity
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 31 Jan 2007.
- Derived from this study: PubMed 20730705Luque-Ramirez M, Escobar-Morreale HF. Treatment of polycystic ovary syndrome (PCOS) with metformin ameliorates insulin resistance in parallel with the decrease of serum interleukin-6 concentrations. Horm Metab Res. 2010 Oct;42(11):815-20. doi: 10.1055/s-0030-1262855. Epub 2010 Aug 20.
- Derived from this study: PubMed 18997670Luque-Ramirez M, Alvarez-Blasco F, Escobar-Morreale HF. Antiandrogenic contraceptives increase serum adiponectin in obese polycystic ovary syndrome patients. Obesity (Silver Spring). 2009 Jan;17(1):3-9. doi: 10.1038/oby.2008.491. Epub 2008 Nov 6.
- Derived from this study: PubMed 18375410Luque-Ramirez M, Alvarez-Blasco F, Uriol Rivera MG, Escobar-Morreale HF. Serum uric acid concentration as non-classic cardiovascular risk factor in women with polycystic ovary syndrome: effect of treatment with ethinyl-estradiol plus cyproterone acetate versus metformin. Hum Reprod. 2008 Jul;23(7):1594-601. doi: 10.1093/humrep/den095. Epub 2008 Mar 27.
- Derived from this study: PubMed 17536071Luque-Ramirez M, Alvarez-Blasco F, Botella-Carretero JI, Sanchon R, San Millan JL, Escobar-Morreale HF. Increased body iron stores of obese women with polycystic ovary syndrome are a consequence of insulin resistance and hyperinsulinism and are not a result of reduced menstrual losses. Diabetes Care. 2007 Sep;30(9):2309-13. doi: 10.2337/dc07-0642. Epub 2007 May 29.
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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.
Héctor F Escobar-Morreale, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Ethynyl-estradiol plus cyproterone acetate in people with Polycystic Ovary Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 2 inclusion and 6 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 31 Jan 2007. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum androgen levels. The study lists 6 primary outcomes in all. 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 NCT00428311, which also lists 4 linked publications.
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 31 Jan 2007.