AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting
on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk
factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic
hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to
usual clinical practice.
METHODOLOGY
Open label, controlled, parallel, prospective study of 12 months of duration, with 2
randomized arms of follow-up:
i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment
randomly allocated to perform scheduled phlebotomies from the third month of treatment to the
end of the study (3 times with a 3-month interval between them).
ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment
randomly allocated to follow-up without bloodletting.
The whole group of patients will undergo a comprehensive anthropometric and hormonal
assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and
carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory
and office blood pressure monitoring, proinflammatory profile, oxidative stress status,
autonomic function assessment, and iron-related metabolism parameters at baseline, after
3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention
Group of patients, and throughout follow-up under treatment with COC in the Control Group of
patients. If a significant relationship between circulating hepcidin levels and elevated
ferritin concentrations is observed, a study of the potential influence of
mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.