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Estromineral Serena Plus and Symptomatic Menopause

NCT ID: NCT01730989

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause

Keywords

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menopause Kupperman hot flushes isoflavones magnolia chaste tree

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Estromineral Serena Plus

Estromineral Serena Plus is an association of soy isoflavones, Lactobacillus sporogenes, magnolia, chaste tree, Vitamin D3, calcium and magnesium.

1 tablet oad for 12 weeks

Group Type EXPERIMENTAL

Estromineral Serena Plus

Intervention Type DIETARY_SUPPLEMENT

Estromineral

Estromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium.

1 tablet oad for 12 weeks

Group Type ACTIVE_COMPARATOR

Estromineral

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Estromineral Serena Plus

Intervention Type DIETARY_SUPPLEMENT

Estromineral

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* female menopausal age
* more than 5 hot flushes/day
* mood or sleep changes

Exclusion Criteria

* hormone replacement therapy
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rottapharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincenzo De Leo, MD

Role: PRINCIPAL_INVESTIGATOR

Siena University

Locations

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Siena University

Siena, Siena, Italy

Site Status

Countries

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Italy

Other Identifiers

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ESP-CPR-0312

Identifier Type: -

Identifier Source: org_study_id