Menopause | Estromineral Serena Plus and Symptomatic Menopause
Menopause research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - female menopausal age - more than 5 hot flushes/day - mood or sleep changes Exclusion Criteria: - hormone replacement therapy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Estromineral Serena Plus
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Estromineral Serena PlusEstromineral Serena Plus is an association of soy isoflavones, Lactobacillus sporogenes, magnolia, chaste tree, Vitamin D3, calcium and magnesium. 1 tablet oad for 12 weeks
EstromineralEstromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium. 1 tablet oad for 12 weeks
Start Date: November 2012
Completed Date: November 2013
Primary Outcome: Kupperman index
Secondary Outcome: Adverse events
Study sponsors, principal investigator, and references
Principal Investigator: Vincenzo De Leo, MD
Lead Sponsor: Rottapharm