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Estromineral Serena Plus and Symptomatic Menopause

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Rottapharm.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Rottapharm
ClinicalTrials.gov Identifier:
NCT01730989
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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 Intervention
Menopause
Dietary Supplement: Estromineral Serena Plus
Dietary Supplement: Estromineral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause

Resource links provided by NLM:


Further study details as provided by Rottapharm:

Primary Outcome Measures:
  • Kupperman index [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Adverse events [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: Yes ]
    Onset duration and severity of adverse events


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hormone replacement therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730989

Locations
Italy
Siena University Not yet recruiting
Siena, Italy, 53100
Principal Investigator: Vincenzo De Leo, MD         
Sponsors and Collaborators
Rottapharm
Investigators
Principal Investigator: Vincenzo De Leo, MD Siena University
  More Information

No publications provided

Responsible Party: Rottapharm
ClinicalTrials.gov Identifier: NCT01730989     History of Changes
Other Study ID Numbers: ESP-CPR-0312
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Rottapharm:
menopause
Kupperman
hot flushes
isoflavones
magnolia
chaste tree

ClinicalTrials.gov processed this record on November 24, 2014