Estromineral Serena Plus and Symptomatic Menopause

Sponsor
Rottapharm (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01730989
Collaborator
(none)
300
1
2
12
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Estromineral Serena Plus
  • Dietary Supplement: Estromineral
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause
Study Start Date :
Nov 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2013
Anticipated Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Dietary Supplement: Estromineral Serena Plus

Active Comparator: Estromineral

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

Dietary Supplement: Estromineral

Outcome Measures

Primary Outcome Measures

  1. Kupperman index [up to 12 weeks]

    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)

Secondary Outcome Measures

  1. Adverse events [4, 8 and 12 weeks]

    Onset duration and severity of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • female menopausal age

  • more than 5 hot flushes/day

  • mood or sleep changes

Exclusion Criteria:
  • hormone replacement therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siena University Siena Italy 53100

Sponsors and Collaborators

  • Rottapharm

Investigators

  • Principal Investigator: Vincenzo De Leo, MD, Siena University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rottapharm
ClinicalTrials.gov Identifier:
NCT01730989
Other Study ID Numbers:
  • ESP-CPR-0312
First Posted:
Nov 21, 2012
Last Update Posted:
Nov 21, 2012
Last Verified:
Nov 1, 2012

Study Results

No Results Posted as of Nov 21, 2012