An interventional study of Phlebotomy and ethinylestradiol in Hyperandrogenism and Metabolic Cardiovascular Syndrome, sponsored by Manuel Luque Ramírez. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Manuel Luque Ramírez · Not applicable, Interventional, and Treatment
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.
Premenopausal women with functional hyperandrogenism defined as:
Exclusion Criteria:
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.
Procedure: Phlebotomy · Drug: ethinylestradiol · Drug: Cyproterone Acetate
Premenopausal women with functional hyperandrogenism under standard combined oral contraceptive pill qd as usual clinical practice.
Drug: ethinylestradiol · Drug: Cyproterone Acetate
Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.
Also known as: Blood donation, Bloodletting
35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.
2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.
Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.
Time frame: one year
Percentage of patients with Hb < 12 g/dl or hematocrit <36% throughout the study
Time frame: one year
Change in the percentage of patients with undiagnosed prediabetes/diabetes between month 0 and 12 of follow-up
Time frame: one year
Change in the Disposition index between month 0 and 12 of follow-up
Time frame: one year
Change in the lipid profile between month 0 and 12 of follow-up
Time frame: one year
Changes in the blood pressure recordings between month 0 and 12 of follow-up
Time frame: one year
Percentage of patients with ferropenia throughout the study
Time frame: one year
Percentage of patients with a hypovolemic event during blood donation
Time frame: one year
Subclinical chronic inflammation
Time frame: one year
Oxidative stress
Time frame: one year
Autonomic vascular function
Time frame: one year
Blood clotting test
Time frame: one year
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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