Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women.

May 20, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Mexico City, Guanajuato, Mexico, 36000
        • Universidad de Guanajuato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • with no history of breast cancer, HRT, morbid obesity, cardiovascular disease, or DM.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prasterone prescription
The participantes were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)
Drug: Prasterone 50 milligram
The participants were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk
Time Frame: Two months
The primary objective is to assess the impact of oral DHEA therapy in perimenopausal women on cardiometabolic indicators.
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk
Time Frame: 0, 4 and 8 weeks

Assessing the effects of oral dehydroepiandrosterone (DHEA) therapy using the following indices:

  1. Triglyceride-Glucose Index (insulin resistance) Formula: ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL)] / 2
  2. Triglyceride HDL-Cholesterol Index (HDL-C = high-density lipoprotein cholesterol) (Dyslipidemia; correlated with high-sensitivity C-reactive protein and metabolic syndrome) Formula: Triglycerides / HDL-cholesterol
  3. Waist-to-Height Ratio (Abdominal obesity) Formula: Waist circumference (cm) / Height (cm)
  4. Cardiometabolic Index (The relationship between total cholesterol and HDL cholesterol) Formula: Waist-to-height ratio (cm) × [Triglycerides / HDL-cholesterol ((mg/dL)]
  5. Lipid Accumulation Product Index (Oxidative) Formula: [Waist circumference (cm) - 58] × Triglycerides (mg/dL)
  6. Visceral Adiposity Index Formula: { Waist circumference (cm) / [ 36.58 + (1.89 × body mass index (kg/m) ] } × { (Triglycerides (mg/dL) / 0.81) × (1.52 / HDL-cholesterol (mg/dL)) }
0, 4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Investigators

  • Principal Investigator: Lorena Ibarra Reynoso, PhD, Universidad de Guanajuato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

January 10, 2021

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIBIUG-P38-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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