Clinical Trials Logo
  1. Home
  2. Hyperandrogenism
  3. NCT02460445

Phlebotomy and Polycystic Ovary Syndrome

Hyperandrogenism Clinical Trial

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

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02460445
Study type Interventional
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date June 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05112029 - Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
Terminated NCT01428193 - Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone N/A
Enrolling by invitation NCT04485403 - The Effect of Ibuprofen on Women With PCOS. Phase 2
Active, not recruiting NCT00930007 - Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone
Completed NCT03252223 - Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS Phase 4
Terminated NCT02523898 - Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant Phase 2
Recruiting NCT04723862 - Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism? Early Phase 1
Suspended NCT02611128 - Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia
Recruiting NCT04453306 - Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome Phase 4
Recruiting NCT04979377 - Prevalence of Hyperandrogenism in Type 1 Diabetes
Recruiting NCT05926115 - Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.
Active, not recruiting NCT01569425 - Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01428089 - Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone Phase 1
Active, not recruiting NCT01421810 - Ovarian Contribution to Androgen Production in Adolescent Girls N/A
Completed NCT01313455 - Adrenal Hyperplasia Among Young People With PCOS
Completed NCT03188640 - Bariatric Surgery, Hormones, and Quality of Life N/A
Not yet recruiting NCT02402413 - Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT02651636 - Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women N/A
Recruiting NCT00929006 - Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism Early Phase 1
Not yet recruiting NCT00665171 - Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome N/A