| Registry | NCT07609043 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 25 (Actual) |
| Sponsor | Universidad de Guanajuato (Other) |
| Conditions | Cardio Metabolic Risk |
| Interventions | Prasterone 50 milligram (Drug) |
| Dates | start 2020-01-10, primary completion 2020-12-20, completion 2021-01-10, first posted 2026-05-27, last updated 2026-05-27 |
| Locations | 1 site in Mexico |
Related Papers Related Patents Related Grants Related Experts
All trials for Cardio Metabolic Risk All trials of Prasterone 50 milligram
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Prasterone prescription | Experimental | Drug: Prasterone 50 milligram | The participantes were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks) |
Sex: Female, ages: 42 Years to any, accepts healthy volunteers
Inclusion Criteria: * with no history of breast cancer, HRT, morbid obesity, cardiovascular disease, or DM. Exclusion Criteria: \-
| Facility | City | Country | Status |
|---|---|---|---|
| Universidad de Guanajuato | Mexico City, Guanajuato | Mexico |