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NCT Number: NCT02460445

Phlebotomy and Polycystic Ovary Syndrome

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.

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Key information

Conditions

Hyperandrogenism 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Autonomic Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Cardiovascular Syndrome Metabolic Diseases Metabolic Syndrome Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Primary Dysautonomias Urogenital Abnormalities Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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)

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Phlebotomy

Procedure

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

Other names: Blood donation, Bloodletting

Ethinylestradiol

Drug

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

cyproterone acetate

Drug

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

Primary outcomes

  1. Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.

    Time frame: one year

  2. Percentage of patients with Hb < 12 g/dl or hematocrit <36% throughout the study

    Time frame: one year

Secondary outcomes

  1. Change in the percentage of patients with undiagnosed prediabetes/diabetes between month 0 and 12 of follow-up

    Time frame: one year

  2. Change in the Disposition index between month 0 and 12 of follow-up

    Time frame: one year

  3. Change in the lipid profile between month 0 and 12 of follow-up

    Time frame: one year

  4. Changes in the blood pressure recordings between month 0 and 12 of follow-up

    Time frame: one year

  5. Percentage of patients with ferropenia throughout the study

    Time frame: one year

  6. Percentage of patients with a hypovolemic event during blood donation

    Time frame: one year

Other outcomes

  1. Subclinical chronic inflammation

    Time frame: one year

  2. Oxidative stress

    Time frame: one year

  3. Autonomic vascular function

    Time frame: one year

  4. Blood clotting test

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Manuel Luque Ramírez

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2015
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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