MenopauseNCT01730989
Estromineral Serena Plus and Symptomatic Menopause
A study testing Estromineral Serena Plus and Estromineral in people with Menopause, run by Rottapharm at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Estromineral Serena Plus and Estromineral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female menopausal age
- more than 5 hot flushes/day
- mood or sleep changes
Who cannot join
- hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause
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.
Read more
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.
- Conditions
- Menopause
- Being tested
- Estromineral Serena Plus, Estromineral
- Keywords
- menopause, Kupperman, hot flushes, isoflavones, magnolia, chaste tree
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estromineral Serena PlusDietary supplement
EstromineralDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Estromineral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 12 weeks
Secondary outcomes (1)
Adverse events
Onset duration and severity of adverse events
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rottapharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincenzo De Leo, MD, Principal investigator, Siena University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730989
- Sponsor's protocol ID
- ESP-CPR-0312
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause
- ClinicalTrials.gov ID
- NCT01730989
- Acronym / sponsor ID
- ESP-CPR-0312
- Conditions
- Menopause
- Keywords
- menopause, Kupperman, hot flushes, isoflavones, magnolia, chaste tree
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RottapharmIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estromineral Serena Plus | Experimental | Dietary Supplement: 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 |
| Estromineral | Active comparator | Dietary Supplement: EstromineralEstromineral is an association of soy isoflavones, Lactobacillus sporogenes, Vitamin D3, and calcium. 1 tablet oad for 12 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female menopausal age
- more than 5 hot flushes/day
- mood or sleep changes
Key exclusion criteria (1 listed)
- hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estromineral Serena Plus | Dietary supplement | Estromineral Serena Plus |
| Estromineral | Dietary supplement | Estromineral |
Primary outcome
Kupperman index
Time frame: 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)
1 secondary outcome
Adverse events
Time frame: 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo De Leo, MD principal investigator
Siena University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estromineral Serena Plus and Estromineral in people with Menopause, run by Rottapharm at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kupperman index (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.