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Polycystic Ovary SyndromeNCT03841981

Body Fat as Determinant of Female Gonadal Dysfunction

An observational study of Polycystic Ovary Syndrome and Hypothalamic Amenorrhea, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal 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
Search all trials

Trial summary

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Anthropometric and physical examination, Indirect calorimetry, accelerometer and seven-day dietary recall and Biochemical, hormonal and metabolic phenotyping
How many people
50 participants
Where
1 siteSpain
Study dates
31 Jan 2020to 31 Dec 2025
Phase
Observational
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients with exercise-associated functional amenorrhea and polycystic ovary syndrome will be consecutively recruited from our Reproductive Endocrinolgy clinic. Those premenopausal adult women are referred to clinic because of symptoms of functional androgen excess such as hirsutism or menstrual dysfunction. The control group (Groups IV and V) will include healthy female volunteers recruited - contemporarily with the recruitment of patients - from the hospital's staff and overweight or obese women seeking medical attention in our department.

Who may be able to join

  • Group I
  • Body mass index between 18.5 and 25.0 kg/m2.
  • Group 1 ovulatory dysfunction [World Health Organization (WHO) classification].
  • Normal/low gonadotrophin levels [follicle-stimulating hormone (FSH) and luteinizing (LH) < 10 IU/l] and low estradiol (< 50 pg/ml).
  • Moderate-vigorous intensity physical activity (> 5 hours per week) plus low energy availability (< 30 kcal/per kg of lean mass).

Who cannot join

  • Informed consent signed.
  • Group II:
  • Polycystic ovary syndrome phenotype I, II and III [National Institute of Health (NIH)-2012] with hyperandrogenemia (http://prevention.nih.gov/workshops/2012/resources.aspx).
  • Body mass index between 18.5 and 40.0 kg/m2.
  • Informed consent signed.
  • Group III:
Show all 26Show fewer
  • Polycystic ovary syndrome phenotype IV (NIH-2012) (http://prevention.nih.gov/workshops/2012/resources.aspx).
  • Body mass index between 18.5 and 40.0 kg/m2.
  • Informed consent signed.
  • Group IV:
  • Body mass index between 18.5 and 25.0 kg/m2.
  • Regular menses.
  • Normal gonadotropins and estradiol levels at follicular phase.
  • Moderate-vigorous intensity physical activity (> 5 hours per week) with normal energy availability (> 30 kcal/per kg of lean mass).
  • Informed consent signed.
  • Group V:
  • No signs or symptoms of hyperandrogenism.
  • No exercise or mild intensity physical activity.
  • Regular menses.
  • Body mass index between 18.5 and 40.0 kg/m2.
  • Informed consent signed.
  • Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and/or opioids) for the previous 6 months to study inclusion.
  • Current pregnancy or lactation, or during the previous 6 months to study inclusion.
  • Asherman's syndrome or outflow tract disorders.
  • Current smoking or alcohol intake > 40 g per day.
  • Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Endocrinology and Nutrition

    Madrid, Madrid, 28034

Other trials in Spain

About this study

Official title: Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be:

Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle.

Read more

Secondary objectives:

  1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution.
  2. To study body composition and body fat distribution in these women and their relationships with:

2.1, Sex steroid profiles.

2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure.

2.3 Markers of low-grade chronic inflammation.

2.4. Oxidative stress markers.

2.5. Cardiovascular autonomic function.

2.6. Surrogate markers of subclinical atherosclerosis.

2.7. Circulating concentrations of endocrine disruptors.

2.8. Oral and gut microbiome.

The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

Being tested
Anthropometric and physical examination, Indirect calorimetry, accelerometer and seven-day dietary recall, Biochemical, hormonal and metabolic phenotyping, Sonographic studies, 24-hour Ambulatory blood pressure monitoring
Keywords
Exercise, Sex steroids, Hyperandrogenism, Adipose tissue, Muscle, Proteome, Gene expression, Adipokine, Cardiovascular risk, Microbiome
Medical subject headings
Polycystic Ovary Syndrome, Motor Activity, Hyperandrogenism

What participants receive

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

  • Anthropometric and physical examinationDiagnostic test

    • Weight and height.
    • Waist-to-hip ratio.
    • Body composition: Bioelectrical impedance and [Dual energy X-ray absorptiometry (DEXA)].

  • Indirect calorimetry, accelerometer and seven-day dietary recallDiagnostic test

    Energy availability assessment.

  • Biochemical, hormonal and metabolic phenotypingDiagnostic test

    • Lipid profile.
    • Oral glucose tolerance test: plasma glucose and insulin, insulin sensitivity indices, gastrointestinal hormones, adipokines, oxidative stress markers.
    • Sex steroid profile.
    • Hypothalamic-pituitary-adrenal axis study.
    • Ferrokinetic study.
    • Subclinical chronic inflammatory markers.

  • Sonographic studiesDiagnostic test

    • Polycystic ovarian morphology.
    • Carotid intima-media thickness.
    • Eco-FAT: Ultrasound measurements of adipose tissue depots including sc, preperitoneal, intraperitoneal (ip), mesenteric, and perirenal fat thickness.

  • 24-hour Ambulatory blood pressure monitoringDiagnostic test

    A\&D TM2430EX oscillometric devices (A\&D Company Limited, Tokyo, Japan).

  • Percutaneous biopsyProcedure or surgery

    Subcutaneous fat tissue and muscle tissue for proteomics an gene expression studies.

  • Cardiovascular autonomic function studiesDiagnostic test

    Parasympathetic and sympathetic responses to deep breathing, Valsalva's maneuver and orthostatism.

  • Oral smear and feces specimenDiagnostic test

    Microbiome studies.

Study groups in NCT03841981
Study groupRoleWhat they receive
I- Hypothalamic amenorrhea10 women with exercise-associated hypothalamic amenorrhea
Receives: Diagnostic Test: Anthropometric and physical examination; Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall; Diagnostic Test: Biochemical, hormonal and metabolic phenotyping; Diagnostic Test: Sonographic studies; Diagnostic Test: 24-hour Ambulatory blood pressure monitoring; Procedure: Percutaneous biopsy; Diagnostic Test: Cardiovascular autonomic function studies; Diagnostic Test: Oral smear and feces specimen
II- Hyperandrogenic polycystic ovary syndrome5 lean women with hyperandrogenic polycystic ovary syndrome. 5 women with weight excess and hyperandrogenic polycystic ovary syndrome.
Receives: Diagnostic Test: Anthropometric and physical examination; Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall; Diagnostic Test: Biochemical, hormonal and metabolic phenotyping; Diagnostic Test: Sonographic studies; Diagnostic Test: 24-hour Ambulatory blood pressure monitoring; Procedure: Percutaneous biopsy; Diagnostic Test: Cardiovascular autonomic function studies; Diagnostic Test: Oral smear and feces specimen
III- Non-hyperandrogenic polycystic ovary syndrome5 lean women with non-hyperandrogenic polycystic ovary syndrome 5 women with weight excess and non-hyperandrogenic polycystic ovary syndrome
Receives: Diagnostic Test: Anthropometric and physical examination; Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall; Diagnostic Test: Biochemical, hormonal and metabolic phenotyping; Diagnostic Test: Sonographic studies; Diagnostic Test: 24-hour Ambulatory blood pressure monitoring; Procedure: Percutaneous biopsy; Diagnostic Test: Cardiovascular autonomic function studies; Diagnostic Test: Oral smear and feces specimen
IV- Trained women without ovulatory dysfunction10 women who exercise as intensively as women with exercise-associated hypothalamic amenorrhea but with normal ovulatory cycles.
Receives: Diagnostic Test: Anthropometric and physical examination; Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall; Diagnostic Test: Biochemical, hormonal and metabolic phenotyping; Diagnostic Test: Sonographic studies; Diagnostic Test: 24-hour Ambulatory blood pressure monitoring; Procedure: Percutaneous biopsy; Diagnostic Test: Cardiovascular autonomic function studies; Diagnostic Test: Oral smear and feces specimen
V- Non-hyperandrogenic healthy women10 women matched by age and body mass index with women with polycystic ovary syndrome who do not perform physical activity on a regular basis
Receives: Diagnostic Test: Anthropometric and physical examination; Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall; Diagnostic Test: Biochemical, hormonal and metabolic phenotyping; Diagnostic Test: Sonographic studies; Diagnostic Test: 24-hour Ambulatory blood pressure monitoring; Procedure: Percutaneous biopsy; Diagnostic Test: Cardiovascular autonomic function studies; Diagnostic Test: Oral smear and feces specimen

What is being measured

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

  1. Adipokine and myokine signaling identification

    Measured: Up to 5 years

Secondary outcomes (14)

  1. Circulating adipokine profile

    At fasting and after an oral glucose challenge: Circulating concentrations of Leptin, Adiponectin, Chemerin, Lipocalin-2, Adipsin, Plasminogen Activator Inhibitor (PAI)-1, Monocyte Chemoattractant Protein (MCP)-1, and Soluble Leptin Receptor by multianalyte profiling on the Luminex Magpix system (Luminex Technologies, Austin, USA.).

    Measured: Up to 5 years

  2. Appetite regulation hormonal profile

    At fasting and after an oral glucose challenge: Circulating concentrations of Amylin, C-Peptide, Ghrelin, Gastric Inhibitory Peptide (GIP), Glucagon-Like Peptide (GLP)-1, Glucagon, IL-6, Insulin, Pancreatic Polypeptide (PP), Peptide YY, Tumor Necrosis Factor (TNF)-α by multianalyte profiling on the Luminex Magpix system (Luminex Technologies, Austin, USA.).

    Measured: Up to 5 years

  3. Association between body mass index and sex steroids

    Body mass index in in kg/m^2. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

    Measured: Up to 5 years

  4. Association between percentage of fat mass with respect to total body weight and sex steroids

    Fat mass% by bioelectric impedanciometry and DEXA. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

    Measured: Up to 5 years

  5. Association between percentage of lean mass with respect to total body weight and sex steroids

    Lean mass% by bioelectric impedanciometry and DEXA. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

    Measured: Up to 5 years

  6. Association between body fat depots and sex steroids

    Adipose tissue depots will be estimated using a Toshiba Nemio XG SSA-580A Diagnostic Ultrasound System. Minimum sc and preperitoneal fat thicknesses will be measured at the level of the xyphoid process. Maximum sc fat thickness will be measured at the level of the umbilicus. Intraperitoneal fat thickness will be measured placing a probe transversally in the midline of abdomen, 2 cm above the umbilicus. Three measures of ip fat thickness will be obtained: the distance from the fascia of rectus abdominis muscle to the vertebral column, the distance from the peritoneum to the vertebral column, and the distance from the linea alba to the vertebral column. Perirenal fat thickness will be estimated as the distance from the perirenal fascia to the renal surface. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  7. Association between body composition, sex steroids, and insulin resistance.

    Fat mass, lean mass and body fat depots will be measured as previously described. Fasting glucose and insulin levels will be used for calculating the homeostasis model assessment of insulin resistance (HOMA-IR), and the composite insulin sensitivity index will be estimated from the glucose and insulin concentrations measured during the oral glucose tolerance test. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  8. Association between body composition, sex steroids, and lipids.

    Fat mass, lean mass and body fat depots will be measured as previously described. Circulating HDL-cholesterol and phospholipid levels will be measured by enzymatic methods after precipitation of plasma with phosphotungstic acid and Mg2+. Total cholesterol and triglyceride levels will be determined by enzymatic methods. LDL-cholesterol concentrations will be estimated by Friedewald's equation. Circulating apolipoprotein (Apo) AI, Apo B100, and lipoprotein (a) levels will be determined by kinetic immunonephelometry. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  9. Association between body composition, sex steroids, and office blood pressure.

    Fat mass, lean mass and body fat depots will be measured as previously described. Office blood pressure will be determined as the mean of three manual sphygmomanometer readings in the sitting position. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  10. Association between body composition, sex steroids, and ambulatory blood pressure monitoring parameters.

    Fat mass, lean mass and body fat depots will be measured as previously described. Twenty-four-hour ambulatory blood pressure monitoring will be performed using an A\&D TM2430EX oscillometric device (A\&D Co., Ltd., Tokyo, Japan). The cuff (12 × 22 cm for lean participants, 14 × 30 cm for overweight or obese participants) will placed on the nondominant arm in every woman. The period from 0700 to 2300 h will be considered daytime, and from 2300 until 0700 h the next day will be considered nighttime, reflecting the usual sleeping habits of Spaniards. Systolic, diastolic, and mean blood pressure as well as heart rate will be measured every 20 min during daytime and every 30 min during nighttime. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  11. Association between body composition, sex steroids, and cardiovascular autonomic function tests.

    Fat mass, lean mass and body fat depots will be measured as previously described. Cardiovascular autonomic function will be assessed by the blood pressure and heart rate responses to active standing, and Ewing and Clarke's tests. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  12. Association between body composition, sex steroids, and carotid intima-media thickness.

    Fat mass, lean mass and body fat depots will be measured as previously described. Imaging will be conducted using a high-resolution 7.5-MHz phased-array transducer by the same trained operator in all the participants. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  13. Association between body composition, sex steroids, and oxidative stress.

    Fat mass, lean mass and body fat depots will be measured as previously described. Oxidative stress profile will be measured by enzymatic assays: Plasma thiobarbituric acid reactive substances, total antioxidant capacity, nitrotyrosine, protein carbonyl groups and erythrocyte glutathione peroxidase levels. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

  14. Association between body composition, sex steroids, and microbiome

    Participants will be instructed to collect fecal and salivary samples. DNA samples wil be used for massive sequencing of 16S ribosomal DNA (rDNA) amplicons in a MiSeq platform (Illumina). The bacterial diversity will be estimated by using Shannon, Chao 1, Jaccard, and Sorensen indexes with their SDs. Taxonomic affiliations will be assigned by using the RDP_classifier from the Ribosomal Database Project (RDP), and readings with RDP score value <0.8 will be assigned to the upper taxonomic rank, leaving the last rank as unidentified. Sex steroids will be measured as previously described.

    Measured: Up to 5 years

Timeline

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

  1. First posted15 Feb 2019
  2. Study start31 Jan 2020
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841981
Sponsor's protocol ID
PI18/01122
Status last verified
Sep 2026
First submitted
8 Feb 2019
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will deposit any datasets and supplemental materials to a generalist repository. The investigators will refer to the deposited material as an item in the bibliography of any manuscript and number the reference appropriately within the text.

Publications

  • Ortiz-Flores AE, Luque-Ramirez M, Fernandez-Duran E, Alvarez-Blasco F, Escobar-Morreale HF. Diagnosis of disorders of glucose tolerance in women with polycystic ovary syndrome (PCOS) at a tertiary care center: fasting plasma glucose or oral glucose tolerance test? Metabolism. 2019 Apr;93:86-92. doi: 10.1016/j.metabol.2019.01.015. Epub 2019 Jan 30.

    PubMed 30710572

  • Luque-Ramirez M, Jimenez-Mendiguchia L, Garcia-Cano A, Fernandez-Duran E, de Dios Rosa V, Nattero-Chavez L, Ortiz-Flores AE, Escobar-Morreale HF. Certified testosterone immunoassays for hyperandrogenaemia. Eur J Clin Invest. 2018 Dec;48(12):e13029. doi: 10.1111/eci.13029. Epub 2018 Oct 8.

    PubMed 30229887

  • Insenser M, Murri M, Del Campo R, Martinez-Garcia MA, Fernandez-Duran E, Escobar-Morreale HF. Gut Microbiota and the Polycystic Ovary Syndrome: Influence of Sex, Sex Hormones, and Obesity. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2552-2562. doi: 10.1210/jc.2017-02799.

    PubMed 29897462

  • Escobar-Morreale HF. Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment. Nat Rev Endocrinol. 2018 May;14(5):270-284. doi: 10.1038/nrendo.2018.24. Epub 2018 Mar 23.

    PubMed 29569621

  • Escobar-Morreale HF. The Role of Androgen Excess in Metabolic Dysfunction in Women : Androgen Excess and Female Metabolic Dysfunction. Adv Exp Med Biol. 2017;1043:597-608. doi: 10.1007/978-3-319-70178-3_26.

    PubMed 29224112

  • Montes-Nieto R, Insenser M, Murri M, Fernandez-Duran E, Ojeda-Ojeda M, Martinez-Garcia MA, Luque-Ramirez M, Escobar-Morreale HF. Plasma thiobarbituric acid reactive substances (TBARS) in young adults: Obesity increases fasting levels only in men whereas glucose ingestion, and not protein or lipid intake, increases postprandial concentrations regardless of sex and obesity. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700425. Epub 2017 Aug 29.

    PubMed 28722287

  • Escobar-Morreale HF, Martinez-Garcia MA, Montes-Nieto R, Fernandez-Duran E, Temprano-Carazo S, Luque-Ramirez M. Effects of glucose ingestion on circulating inflammatory mediators: Influence of sex and weight excess. Clin Nutr. 2017 Apr;36(2):522-529. doi: 10.1016/j.clnu.2016.01.015. Epub 2016 Jan 29.

    PubMed 26874912

  • Insenser M, Montes-Nieto R, Martinez-Garcia MA, Escobar-Morreale HF. A nontargeted study of muscle proteome in severely obese women with androgen excess compared with severely obese men and nonhyperandrogenic women. Eur J Endocrinol. 2016 Mar;174(3):389-98. doi: 10.1530/EJE-15-0912. Epub 2015 Dec 15.

    PubMed 26671973

  • Borruel S, Molto JF, Alpanes M, Fernandez-Duran E, Alvarez-Blasco F, Luque-Ramirez M, Escobar-Morreale HF. Surrogate markers of visceral adiposity in young adults: waist circumference and body mass index are more accurate than waist hip ratio, model of adipose distribution and visceral adiposity index. PLoS One. 2014 Dec 5;9(12):e114112. doi: 10.1371/journal.pone.0114112. eCollection 2014.

    PubMed 25479351

  • Luque-Ramirez M, Escobar-Morreale HF. Polycystic ovary syndrome as a paradigm for prehypertension, prediabetes, and preobesity. Curr Hypertens Rep. 2014 Dec;16(12):500. doi: 10.1007/s11906-014-0500-6.

    PubMed 25304109

  • Escobar-Morreale HF, Alvarez-Blasco F, Botella-Carretero JI, Luque-Ramirez M. The striking similarities in the metabolic associations of female androgen excess and male androgen deficiency. Hum Reprod. 2014 Oct 10;29(10):2083-91. doi: 10.1093/humrep/deu198. Epub 2014 Aug 7.

    PubMed 25104855

  • Murri M, Insenser M, Luque M, Tinahones FJ, Escobar-Morreale HF. Proteomic analysis of adipose tissue: informing diabetes research. Expert Rev Proteomics. 2014 Aug;11(4):491-502. doi: 10.1586/14789450.2014.903158. Epub 2014 Mar 31.

    PubMed 24684164

  • Murri M, Insenser M, Escobar-Morreale HF. Metabolomics in polycystic ovary syndrome. Clin Chim Acta. 2014 Feb 15;429:181-8. doi: 10.1016/j.cca.2013.12.018. Epub 2013 Dec 22.

    PubMed 24368231

  • Luque-Ramirez M, Marti D, Fernandez-Duran E, Alpanes M, Alvarez-Blasco F, Escobar-Morreale HF. Office blood pressure, ambulatory blood pressure monitoring, and echocardiographic abnormalities in women with polycystic ovary syndrome: role of obesity and androgen excess. Hypertension. 2014 Mar;63(3):624-9. doi: 10.1161/HYPERTENSIONAHA.113.02468. Epub 2013 Dec 9.

    PubMed 24324038

  • Escobar-Morreale HF. Reproductive endocrinology: Menstrual dysfunction--a proxy for insulin resistance in PCOS? Nat Rev Endocrinol. 2014 Jan;10(1):10-1. doi: 10.1038/nrendo.2013.232. Epub 2013 Nov 26. No abstract available.

    PubMed 24275746

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome and Hypothalamic Amenorrhea, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal 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 5 inclusion and 26 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 16 Sep 2026. 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?

Adipokine and myokine signaling identification (time frame: Up to 5 years). 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 NCT03841981, which also lists 28 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 16 Sep 2026.

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