Phlebotomy and Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Hyperandrogenism Metabolic Cardiovascular Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Phlebotomy

Intervention Type PROCEDURE

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

ethinylestradiol

Intervention Type DRUG

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

Cyproterone Acetate

Intervention Type DRUG

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

Control

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

Group Type ACTIVE_COMPARATOR

ethinylestradiol

Intervention Type DRUG

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

Cyproterone Acetate

Intervention Type DRUG

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

Interventions

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Phlebotomy

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

Intervention Type PROCEDURE

ethinylestradiol

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

Intervention Type DRUG

Cyproterone Acetate

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

Intervention Type DRUG

Other Intervention Names

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Blood donation Bloodletting

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Combined oral contraceptive pill indication for treatment: i) hyperandrogenism-related dermo-cosmetic complaints with psychoemotional impact; ii) endometrial protection; and/or iii) contraception desire.
3. Scheduled phlebotomy acceptation if randomly allocated.
4. Signed informed consent.

Exclusion Criteria

1. Contraindication for blood donation.
2. Plasma ferritin \< 76 pmol/l and/or transferrin saturation percent \< 15%.
3. Anemia (plasma hemoglobin \< 12 g/dl or hematocrit \< 36%).
4. Chronic kidney disease (eGFR \< 60 ml/min per 1.73 m2).
5. Personal history of dyslipidemia, hypertension, prediabetes, diabetes mellitus, gestational diabetes or cardiovascular events.
6. 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.
7. Previous surgical treatment for PCOS.
8. History of blood donation for the previous 12 months to inclusion.
9. Current history of infectious disease, inflammatory disease, liver disease, neurologic disease or malignancy.
10. Eating disorders. Body mass index \< 18.5 Kg/m2.
11. Hereditary hemochromatosis.
12. Celiac disease or malabsorptive disorder.
13. Contraindication for treatment with combined oral contraceptives.
14. Pregnancy.
15. Current smoking, recreational drug use or excessive alcohol consumption (\> 40 g per day).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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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.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Manuel Luque Ramírez, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant in Endocrinology. Member of the Diabetes, Obesity and Human Reproduction Research Group from the lnstituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)