Clinical trial NCT00428311: Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
Hyperandrogenism
Hirsutism
Cardiovascular risk
Chronic inflammation
Metformin
Cyproterone acetate
Oral contraceptives
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serum androgen levels
measure: Lipid profiles
measure: Blood pressure
measure: Cardiovascular performance
measure: Non-classic cardiovascular risk markers
measure: Indexes of insulin secretion and sensitivity
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Endocrinology, Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Héctor F Escobar-Morreale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Luque-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.
citation: Luque-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.
citation: Luque-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.