MenopauseESTROCALVINCT01805674
Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women
An observational study of Menopause, run by Rottapharm Spain at 10 sites in Spain.
Trial summary
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life. The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with… Read more about this study
- Who is it for?
- Ages 45 to 59 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- isoflavones combined with magnolia
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 10 sitesSpain
- Study dates
- Mar 2013to Oct 2013
- Phase
- Observational
- 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 59 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will be conducted in patients with typical mild to mderate vasomotor symptoms and psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require specific drug treatment.
Who may be able to join
- Women with at least 12 months of amenorrhea
- Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations
- One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.
- Women must give the informed consent
Who cannot join
- clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases
- Patients with the habit of eating soy foods or dietary supplements with soy extract
- patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)
- patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.
- patients with treatment with antibiotics, antidepressant and/or anxiolytic products
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Somdex S.L.
Barcelona, Barcelona, 08017
Centro Médico Teknon
Barcelona, Barcelona, 08022
Surgery of Dr. Sánchez Muñoz
Ciudad Real, Ciudad Real, 13004
Grupo hospitalario Quirón
Erandio, Vizcaya, 48950
Gabinete Médico Velazquez
Madrid, Madrid, 28001
Clínica ginecológica Cecchini
Oviedo, Oviedo, 33004
Instituto Sevillano de Ginecología y Obstetricia
Seville, Sevilla, 41003
Surgery of Dr. Mahiques
Valencia, Valencia, 46006
Surgery of Dr. Raga
Valencia, Valencia, 46006
Centro Ginecológico Dr. García Pérez-Llantada SL
Zaragoza, Zaragoza, 50008
About this study
Official title: Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.
The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.
Read the detailed description
Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.
The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.
Quality of life will be analyzed by the scale of Cervantes.
- Conditions
- Menopause
- Being tested
- isoflavones combined with magnolia
- Keywords
- menopause, quality of life, soy isoflavones, magnolia extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isoflavones combined with magnoliaDietary supplement
Also called Estromineral Serena
1 tablet/day duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| isoflavones combined with magnolia | A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks. Receives: Dietary Supplement: isoflavones combined with magnolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of life measured by the scale of Cervantes
The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women
Measured: baseline and 12 weeks
Secondary outcomes (1)
Clinical changes in vasomotor symptomatology
In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit
Measured: baseline, 2, 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 posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionOct 2013
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Anguera, MD, PhD, Study director, Rottapharm S.L.Rafael Sánchez-Borrego, MD, Principal investigator, Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805674
- Sponsor's protocol ID
- ESTROCALVI
- Acronym
- ESTROCALVI
- Status last verified
- Nov 2014
- First submitted
- 1 Mar 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract
- ClinicalTrials.gov ID
- NCT01805674
- Acronym / sponsor ID
- ESTROCALVI / ESTROCALVI
- Conditions
- Menopause
- Keywords
- menopause, quality of life, soy isoflavones, magnolia extract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Mar 2013 (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.
In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.
The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.
Detailed description
Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.
The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.
Quality of life will be analyzed by the scale of Cervantes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isoflavones combined with magnolia | – | Dietary Supplement: isoflavones combined with magnoliaA food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will be conducted in patients with typical mild to mderate vasomotor symptoms and psycho symptoms such as mood changes, or sleep, anxiety / depression, which do not require specific drug treatment.
Key inclusion criteria (4 listed)
- Women with at least 12 months of amenorrhea
- Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations
- One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.
- Women must give the informed consent
Key exclusion criteria (5 listed)
- clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases
- Patients with the habit of eating soy foods or dietary supplements with soy extract
- patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)
- patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.
- patients with treatment with antibiotics, antidepressant and/or anxiolytic products
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 |
|---|---|---|
| isoflavones combined with magnoliaAlso: Estromineral Serena1 tablet/day duration: 12 weeks | Dietary supplement | isoflavones combined with magnolia |
Primary outcome
the quality of life measured by the scale of Cervantes
Time frame: baseline and 12 weeks
The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women
1 secondary outcome
Clinical changes in vasomotor symptomatology
Time frame: baseline, 2, 4, 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
Anna Anguera, MD, PhD study director
Rottapharm S.L.
Rafael Sánchez-Borrego, MD principal investigator
Centro Médico Teknon
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Rottapharm Spain at 10 sites in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the quality of life measured by the scale of Cervantes (time frame: baseline and 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 5 Nov 2014.