Phlebotomy and Polycystic Ovary Syndrome
Hyperandrogenism, Metabolic Cardiovascular Syndrome
About this trial
This is an interventional treatment trial for Hyperandrogenism focused on measuring Functional hyperandrogenism, Polycystic ovary syndrome, Idiopathic hyperandrogenism, Iron tissue depots, Phlebotomy, Insulin resistance, Carbohydrate metabolism, Blood pressure, Autonomic dysfunction, Oxidative stress, Blood clotting tests, Efficacy, Side effects, Randomized clinical trial
Eligibility Criteria
Inclusion Criteria:
Premenopausal women with functional hyperandrogenism defined as:
- Polycystic ovary syndrome (PCOS): Clinical and biochemical hyperandrogenism plus ovulatory dysfunction or polycystic ovarian morphology.
- Idiopathic hyperandrogenism: Clinical and biochemical hyperandrogenism with normal ovulatory cycles and normal ovarian morphology.
- Combined oral contraceptive pill indication for treatment: i) hyperandrogenism-related dermo-cosmetic complaints with psychoemotional impact; ii) endometrial protection; and/or iii) contraception desire.
- Scheduled phlebotomy acceptation if randomly allocated.
- Signed informed consent.
Exclusion Criteria:
- Contraindication for blood donation.
- Plasma ferritin < 76 pmol/l and/or transferrin saturation percent < 15%.
- Anemia (plasma hemoglobin < 12 g/dl or hematocrit < 36%).
- Chronic kidney disease (eGFR < 60 ml/min per 1.73 m2).
- Personal history of dyslipidemia, hypertension, prediabetes, diabetes mellitus, gestational diabetes or cardiovascular events.
- Treatment with oral contraceptives, antiandrogens, insulin sensitizers, drugs that might interfere with blood pressure regulation, lipid profile or carbohydrate metabolism, and oral/parenteral iron therapy for the previous 3 months to inclusion.
- Previous surgical treatment for PCOS.
- History of blood donation for the previous 12 months to inclusion.
- Current history of infectious disease, inflammatory disease, liver disease, neurologic disease or malignancy.
- Eating disorders. Body mass index < 18.5 Kg/m2.
- Hereditary hemochromatosis.
- Celiac disease or malabsorptive disorder.
- Contraindication for treatment with combined oral contraceptives.
- Pregnancy.
- Current smoking, recreational drug use or excessive alcohol consumption (> 40 g per day).
Sites / Locations
- Diabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
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.