NCT01730989

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

November 15, 2012

Last Update Submit

November 20, 2012

Conditions

Menopause

Keywords

menopauseKuppermanhot flushesisoflavonesmagnoliachaste tree

Outcome Measures

Primary Outcomes (1)

  • Kupperman index

    To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10)

    up to 12 weeks

Secondary Outcomes (1)

  • Adverse events

    4, 8 and 12 weeks

Study Arms (2)

Estromineral Serena Plus

EXPERIMENTAL

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

Dietary Supplement: Estromineral Serena Plus

Estromineral

ACTIVE COMPARATOR

Estromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium. 1 tablet oad for 12 weeks

Dietary Supplement: Estromineral

Interventions

Estromineral Serena PlusDIETARY_SUPPLEMENT
Estromineral Serena Plus
EstromineralDIETARY_SUPPLEMENT
Estromineral

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siena University

Siena, Siena, 53100, Italy

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vincenzo De Leo, MD

    Siena University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

IT(1)