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HyperandrogenismNCT02460445

Phlebotomy and Polycystic Ovary Syndrome

A study testing Phlebotomy, ethinylestradiol and Cyproterone Acetate in people with Hyperandrogenism and Metabolic Cardiovascular Syndrome, run by Manuel Luque Ramírez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Phlebotomy, ethinylestradiol and Cyproterone Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteSpain
Study dates
Jan 2015to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • 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

Other trials in Spain

About this study

Official title: Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With 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

Read more

Open label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up:

  1. 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.

Being tested
Phlebotomy, ethinylestradiol, Cyproterone Acetate
Keywords
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
Medical subject headings
Hyperandrogenism, Metabolic Syndrome, Polycystic Ovary Syndrome, Insulin Resistance, Primary Dysautonomias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhlebotomyProcedure or surgery

    Also called Blood donation, Bloodletting

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

  • ethinylestradiolDrug

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

  • Cyproterone AcetateDrug

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

Study groups in NCT02460445
Study groupRoleWhat they receive
InterventionExperimentalPremenopausal 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.
Receives: Procedure: Phlebotomy; Drug: ethinylestradiol; Drug: Cyproterone Acetate
ControlActive comparatorPremenopausal women with functional hyperandrogenism under standard combined oral contraceptive pill qd as usual clinical practice.
Receives: Drug: ethinylestradiol; Drug: Cyproterone Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: one year

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

    Measured: one year

Secondary outcomes (6)

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

    Measured: one year

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

    Measured: one year

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

    Measured: one year

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

    Measured: one year

  5. Percentage of patients with ferropenia throughout the study

    Measured: one year

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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2020
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460445
Sponsor's protocol ID
PI14/00649
Status last verified
Jul 2022
First submitted
27 May 2015
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
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.

Publications

  • Ortiz-Flores AE, Martinez-Garcia MA, Nattero-Chavez L, Alvarez-Blasco F, Fernandez-Duran E, Quintero-Tobar A, Escobar-Morreale HF, Luque-Ramirez M. Iron Overload in Functional Hyperandrogenism: In a Randomized Trial, Bloodletting Does Not Improve Metabolic Outcomes. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1559-e1573. doi: 10.1210/clinem/dgaa978.

    PubMed 33462622

  • Luque-Ramirez M, Ortiz-Flores AE, Nattero-Chavez L, Martinez-Garcia MA, Insenser M, Alvarez-Blasco F, Fernandez-Duran E, Quintero-Tobar A, de Lope Quinones S, Escobar-Morreale HF. Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial. Sci Rep. 2021 Nov 11;11(1):22097. doi: 10.1038/s41598-021-01606-7.

    PubMed 34764381

  • Luque-Ramirez M, Ortiz-Flores AE, Martinez-Garcia MA, Insenser M, Quintero-Tobar A, De Lope Quinones S, Fernandez-Duran E, Nattero-Chavez ML, Alvarez-Blasco F, Escobar-Morreale HF. Effect of Iron Depletion by Bloodletting vs. Observation on Oxidative Stress Biomarkers of Women with Functional Hyperandrogenism Taking a Combined Oral Contraceptive: A Randomized Clinical Trial. J Clin Med. 2022 Jul 3;11(13):3864. doi: 10.3390/jcm11133864.

    PubMed 35807149

Questions about this trial

What is this clinical trial studying?

A study testing Phlebotomy, ethinylestradiol and Cyproterone Acetate in people with Hyperandrogenism and Metabolic Cardiovascular Syndrome, run by Manuel Luque Ramírez at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460445, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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