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Trial record 2 of 6 for:    "Sex Development Disorder" | "Contraceptive Agents, Male"

Phlebotomy and Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02460445
Recruitment Status : Active, not recruiting
First Posted : June 2, 2015
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Manuel Luque Ramírez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hyperandrogenism Metabolic Cardiovascular Syndrome Procedure: Phlebotomy Drug: ethinylestradiol Drug: Cyproterone Acetate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome
Actual Study Start Date : January 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: 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.
Procedure: Phlebotomy
Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.
Other Names:
  • Blood donation
  • Bloodletting

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

Drug: Cyproterone Acetate
2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.

Active Comparator: Control
Premenopausal women with functional hyperandrogenism under standard combined oral contraceptive pill qd as usual clinical practice.
Drug: ethinylestradiol
35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.

Drug: Cyproterone Acetate
2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460445


Locations
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Spain
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, Spain, 28034
Sponsors and Collaborators
Manuel Luque Ramírez
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Manuel Luque Ramírez, M.D., Ph.D. Assistant in Endocrinology. Member of the Diabetes, Obesity and Human Reproduction Research Group from the lnstituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)

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Responsible Party: 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., Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02460445     History of Changes
Other Study ID Numbers: PI14/00649
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Manuel Luque Ramírez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
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
Additional relevant MeSH terms:
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46, XX Disorders of Sex Development
Disorders of Sex Development
Contraceptive Agents, Male
Polycystic Ovary Syndrome
Hyperandrogenism
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cyproterone Acetate
Ethinyl Estradiol
Cyproterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists