- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07609043
Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women.
20 mai 2026 mis à jour par: Lorena del Rocio Ibarra Reynoso, Universidad de Guanajuato
Perimenopause is the natural transition period towards menopause, in which the ovarian reserve begins to decrease, and the woman loses her fertility.
It usually starts around the age of 40 and has a variable duration.
It has been identified that the decrease in estrogen levels leads to the development of metabolic and cardiovascular complications, such as metabolic syndrome.
Dehydroepiandrosterone (DHEA) is a hormone that converts to testosterone and estrogen and is mainly associated with age-related changes in cardiovascular tissues and metabolism, among others.
This hormone declines with age, contributing to the development of age-related disorders, such as cardiovascular disease.
In theory, DHEA has beneficial effects in regulating glucose and lipid metabolism and in ameliorating obesity.
It is hypothesized that DHEAS and cardiovascular disease may share causal pathways, for example, nitric oxide synthesis and endothelial cell damage.
In addition, it has been observed that the administration of DHEA significantly reduces the level of triglycerides and improves insulin sensitivity.
There are few studies focused on the perimenopause stage and none of them focused on the prevention of cardiometabolic risk.
Therefore, evaluating the impact of prasterone on cardiometabolic indicators in premenopausal women is essential.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Perimenopause is the natural transition period towards menopause, in which the ovarian reserve begins to decrease, and the woman loses her fertility.
It usually starts around the age of 40 and has a variable duration.
It has been identified that the decrease in estrogen levels leads to the development of metabolic and cardiovascular complications, such as metabolic syndrome.
Dehydroepiandrosterone (DHEA) is a hormone that converts to testosterone and estrogen and is primarily associated with age-related changes in cardiovascular tissues, female fertility, and metabolism, among others.
This hormone gradually declines with age, contributing to the development of age-related disorders, such as cardiovascular disease.
In theory, DHEA has beneficial effects in regulating glucose and lipid metabolism and in ameliorating obesity.
Previous studies have shown that DHEA is inversely associated with cholesterol levels, obesity, and diabetes, playing an important preventive role in cardiovascular disease.
It is hypothesized that DHEAS and cardiovascular disease may share causal pathways, for example, nitric oxide synthesis and endothelial cell damage.
Some studies in premenopausal women found inverse correlations between serum DHEA concentrations and body weight.
Besides.
It has been observed that the administration of DHEA significantly reduces the level of triglycerides and improves insulin sensitivity.
A meta-analysis showed that DHEAS was lower in patients with coronary disease, therefore, it is suggested that low levels of DHEAS may be a risk factor for coronary disease, affecting quality of life, and increasing the risks that predispose to metabolic diseases.
Most of the studies where DHEA is administered are focused on the menopause stage, there being few studies focused on the perimenopause stage and none of them on the prevention of Cardiometabolic risk.
For this reason, it is important to carry out studies to find out the effects that prasterone has on cardiometabolic indicators and that can contribute to the understanding of these processes before menopause appears.
This study was conducted in 25 women older than 42 years in the perimenopausal stage, with no history of breast cancer, hormonal replacement therapy , morbid obesity, cardiovascular disease, or diabetes mellitus.
They were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (baseline, one month and two months).
Anthropometric (weight, height, waist and hip circumference) and biochemical (glucose and cholesterol, triglycerides, HDL, LDL and VLDL) variables were evaluated, as well as blood pressure.
Cardiometabolic risk predictors were evaluated, such as the triglyceride-glycemia index, the triglyceride/HDL-C index, the waist-height index (WHtR), the cardiometabolic index, the Lipid Accumulation Product and visceral adiposity index.
Type d'étude
Interventionnel
Inscription (Réel)
25
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Guanajuato
-
Mexico City, Guanajuato, Mexique, 36000
- Universidad de Guanajuato
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- with no history of breast cancer, HRT, morbid obesity, cardiovascular disease, or DM.
Exclusion Criteria:
-
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Prasterone prescription
The participantes were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)
|
The participants were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiometabolic risk
Délai: Two months
|
The primary objective is to assess the impact of oral DHEA therapy in perimenopausal women on cardiometabolic indicators.
|
Two months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiometabolic risk
Délai: 0, 4 and 8 weeks
|
Assessing the effects of oral dehydroepiandrosterone (DHEA) therapy using the following indices:
|
0, 4 and 8 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Lorena Ibarra Reynoso, PhD, Universidad de Guanajuato
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Anagnostis P, Bitzer J, Cano A, Ceausu I, Chedraui P, Durmusoglu F, Erkkola R, Goulis DG, Hirschberg AL, Kiesel L, Lopes P, Pines A, van Trotsenburg M, Lambrinoudaki I, Rees M. Menopause symptom management in women with dyslipidemias: An EMAS clinical guide. Maturitas. 2020 May;135:82-88. doi: 10.1016/j.maturitas.2020.03.007. Epub 2020 Mar 16.
- Rabijewski M, Papierska L, Binkowska M, Maksym R, Jankowska K, Skrzypulec-Plinta W, Zgliczynski W. Supplementation of dehydroepiandrosterone (DHEA) in pre- and postmenopausal women - position statement of expert panel of Polish Menopause and Andropause Society. Ginekol Pol. 2020;91(9):554-562. doi: 10.5603/GP.2020.0091.
- Teixeira CJ, Veras K, de Oliveira Carvalho CR. Dehydroepiandrosterone on metabolism and the cardiovascular system in the postmenopausal period. J Mol Med (Berl). 2020 Jan;98(1):39-57. doi: 10.1007/s00109-019-01842-5. Epub 2019 Nov 12.
- Vegunta S, Kling JM, Kapoor E. Androgen Therapy in Women. J Womens Health (Larchmt). 2020 Jan;29(1):57-64. doi: 10.1089/jwh.2018.7494. Epub 2019 Nov 5.
- Sahu P, Gidwani B, Dhongade HJ. Pharmacological activities of dehydroepiandrosterone: A review. Steroids. 2020 Jan;153:108507. doi: 10.1016/j.steroids.2019.108507. Epub 2019 Oct 3.
- Teixeira CJ, Ribeiro LM, Veras K, da Cunha Araujo LC, Curi R, de Oliveira Carvalho CR. Dehydroepiandrosterone supplementation is not beneficial in the late postmenopausal period in diet-induced obese rats. Life Sci. 2018 Jun 1;202:110-116. doi: 10.1016/j.lfs.2018.03.052. Epub 2018 Mar 27.
- Oh H, Wild RA, Manson JE, Bea JW, Shadyab AH, Pfeiffer RM, Saquib N, Underland L, Anderson GL, Xu X, Trabert B. Obesity, Height, and Serum Androgen Metabolism among Postmenopausal Women in the Women's Health Initiative Observational Study. Cancer Epidemiol Biomarkers Prev. 2021 Nov;30(11):2018-2029. doi: 10.1158/1055-9965.EPI-21-0604. Epub 2021 Aug 26.
- Tang J, Chen LR, Chen KH. The Utilization of Dehydroepiandrosterone as a Sexual Hormone Precursor in Premenopausal and Postmenopausal Women: An Overview. Pharmaceuticals (Basel). 2021 Dec 29;15(1):46. doi: 10.3390/ph15010046.
- Martinez-Garcia G, Rodriguez-Ramos M, Santos-Medina M, Mata-Cuevas LA, Carrero-Vazquez AM, Chipi-Rodriguez Y. Triglyceride-glucose index impact on in-hospital mortality in acute myocardial infarction. Results from the RECUIMA multicenter registry. Gac Med Mex. 2022;158(2):83-89. doi: 10.24875/GMM.M22000646.
- Lu Y, Liu S, Qiao Y, Li G, Wu Y, Ke C. Waist-to-height ratio, waist circumference, body mass index, waist divided by height0.5 and the risk of cardiometabolic multimorbidity: A national longitudinal cohort study. Nutr Metab Cardiovasc Dis. 2021 Aug 26;31(9):2644-2651. doi: 10.1016/j.numecd.2021.05.026. Epub 2021 Jun 4.
- Liu X, Wu Q, Yan G, Duan J, Chen Z, Yang P, Bragazzi NL, Lu Y, Yuan H. Cardiometabolic index: a new tool for screening the metabolically obese normal weight phenotype. J Endocrinol Invest. 2021 Jun;44(6):1253-1261. doi: 10.1007/s40618-020-01417-z. Epub 2020 Sep 9.
- Wu TT, Gao Y, Zheng YY, Ma YT, Xie X. Association of endogenous DHEA/DHEAS with coronary heart disease: A systematic review and meta-analysis. Clin Exp Pharmacol Physiol. 2019 Nov;46(11):984-994. doi: 10.1111/1440-1681.13146. Epub 2019 Aug 29.
- Wakabayashi I, Daimon T. The "cardiometabolic index" as a new marker determined by adiposity and blood lipids for discrimination of diabetes mellitus. Clin Chim Acta. 2015 Jan 1;438:274-8. doi: 10.1016/j.cca.2014.08.042. Epub 2014 Sep 6.
- Baez-Duarte BG, Zamora-Ginez I, Rodriguez-Ramirez SO, Pesqueda-Cendejas LK, Garcia-Aragon KH. TG/HDL index to identify subjects with metabolic syndrome in the Mexican population. Gac Med Mex. 2022;158(5):259-264. doi: 10.24875/GMM.M22000693.
- Farinola MG, Sganga M. [Cut-off points of anthropometric markers for hypertension and hyperglycemia in Argentine adults: a cross-sectional study from the 4th ENFR]. Rev Fac Cien Med Univ Nac Cordoba. 2022 Sep 16;79(3):260-266. doi: 10.31053/1853.0605.v79.n3.37313. Spanish.
- Qiao T, Luo T, Pei H, Yimingniyazi B, Aili D, Aimudula A, Zhao H, Zhang H, Dai J, Wang D. Association between abdominal obesity indices and risk of cardiovascular events in Chinese populations with type 2 diabetes: a prospective cohort study. Cardiovasc Diabetol. 2022 Nov 1;21(1):225. doi: 10.1186/s12933-022-01670-x.
- Vega-Cardenas M, Flores-Sanchez J, Torres-Rodriguez ML, Sanchez-Armass Capello O, Vargas-Morales JM, Cossio-Torres PE, Teran-Garcia M, Aradillas-Garcia C. [Distribution of triglycerides and glucose (TyG) index and homeostasis model assessment insulin resistance for the evaluation of insulin sensitivity on late adolescence in Mexicans]. Nutr Hosp. 2022 Dec 20;39(6):1349-1356. doi: 10.20960/nh.04120. Spanish.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 janvier 2020
Achèvement primaire (Réel)
20 décembre 2020
Achèvement de l'étude (Réel)
10 janvier 2021
Dates d'inscription aux études
Première soumission
1 avril 2023
Première soumission répondant aux critères de contrôle qualité
20 mai 2026
Première publication (Réel)
27 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CIBIUG-P38-2016
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .