Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Thrombosis

Metabolic Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Autonomic Nervous System Diseases

Primary Dysautonomias

Hyperandrogenism

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Reproductive Control Agents

Antineoplastic Agents

Insulin

Insulin, Globin Zinc

Iron

Ethinyl Estradiol

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Combined

Cyproterone Acetate

Cyproterone

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Estrogens

Hormones

Hormone Antagonists

Androgens

Androgen Antagonists

Contraceptive Agents, Male

Premenopausal women with functional hyperandrogenism under combined oral contraceptive pill qd as usual clinical practice who will undergo a scheduled standard phlebotomy every 3 months from month 3 to 12 of follow-up.

Premenopausal women with functional hyperandrogenism under standard combined oral contraceptive pill qd as usual clinical practice.

Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.

Phlebotomy

35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.

ethinylestradiol

2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.

Manuel Luque Ramírez, M.D., Ph.D.

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.

Phlebotomy and Polycystic Ovary Syndrome

Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome

All data sets generated during and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

Instituto de Salud Carlos III

Manuel Luque Ramírez

Member of the Diabetes, Obesity and Human Reproduction Research Group, Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas CIBERDEM.

Spots Global Cancer Trial Database for metabolic cardiovascular syndrome