Menopause Clinical Trial
Official title:
Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause
Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night
sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality
of life. The gradual decline of oestrogen from peri-menopause results in altered function of
many neurotransmitters, such as dopamine, melatonin and neuropeptides including
beta-endorphins, which modulate the function of the hypothalamus and are involved in body
thermoregulation.
In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2
receptors is effective in relieving hot flushes and in reducing the accompanying
psychological symptoms.
The use of hormone replacement therapy, which is generally prescribed in the case of
moderate or severe symptoms, is limited due to real contraindications or simply the woman's
refusal to take the therapy, despite the presence of symptoms requiring its use.
A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones,
the absorption of which is increased by the presence of Lactobacillus sporogenes, and
Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at
reducing vasomotor symptoms.
To potentiate the effect of E on the most frequent symptoms in menopause, it was considered
rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste
tree, acting on both hot flushes and psychological symptoms and a new food supplement was
developed: Estromineral Serena Plus (ESP).
Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste
tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
| Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
| Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
| Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
| Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
| Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
| Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
| Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
| Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
| Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
| Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
| Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
| Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
| Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
| Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
| Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
| Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |