MenopauseOLSEMNCT03875430
Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
An observational study of Menopause, run by Aristo Pharma Iberia.
Trial summary
This observational study will assess the effects of a dietary supplement based on Humulus Lupulus L. to relieve the symptoms of menopause in perimenopausal and postmenopausal women, by doing a follow up of the Cervantes scale and the Anxiety and depression Goldberg Scale in a period of 6 months. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Humulus lupulus L
- Type of treatment
- Pill or oral medicine
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2019to 30 Oct 2019
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 40 and 60 years old that attend ginecological consultation in Spain.
Who may be able to join
- Perimenopausal according to the Stages of Reproductive Aging Workshop (STRAW) or postmenopausal women between the ages of 40 and 60.
- Having moderate or severe hot flushes.
- Accepting and signing the Informed consent.
Who cannot join
- Women unable to answer the questionnaires.
- Women being treated with sulfonamides, methotrexate, triamterene, sulfasalazine, estrogens, phenytoin, anxiolytics, antidepressants, daily multivitamins, hormonal therapy, use of oral contraceptives in the last 3 months, herbal products to reduce vasomotor symptoms in the last months.
- Women in treatment and control for psychiatric pathology.
- Women with any comorbidity that could be the cause of a symptomatology coinciding but not bound to peri or post-menopause.
- Women diagnosed or with Clinical suspicion of breast cancer, endometrium or other hormone-dependent tumors, genital tract bleeding, actives thromboembolic disorders, active gall bladder illness or being lactose intolerant.
- Women being treated with antithyroid medications and other drugs like letrozole, raloxifene, bazedoxifene, bethanechol, desmopressin and calcitonin or other drugs that at investigators judgement could interfere in the study's result.
- Use of dietary supplements that include phytoestrogens (drinks or desserts based in soya) in the last month.
- Women with coronary diseases, strokes or chronic renal diseases, type 2 diabetes, deep vein thrombosis or pulmonary embolism.
About this study
Official title: Multicenter Prospective Observational Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
This observational study will assess the effects of a dietary supplement based on Humulus Lupulus L. to relieve the symptoms of menopause in perimenopausal and postmenopausal women, by doing a follow up of the Cervantes scale and the Anxiety and depression Goldberg Scale in a period of 6 months. Participants will be allocated to dietary supplement being the difference between groups if they are perimenopausal or postmenopausal, and will attend to 3 visits (baseline, 3 months and 6 months).
- Conditions
- Menopause
- Being tested
- Humulus lupulus L
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humulus lupulus LDietary supplement
Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause
| Study group | Role | What they receive |
|---|---|---|
| Perimenopausal | Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. Receives: Dietary Supplement: Humulus lupulus L | |
| Postmenopausal | Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. Receives: Dietary Supplement: Humulus lupulus L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale
Score on the Cervantes Scale on quality of life.
The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Measured: Change from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health.
This domain of the Cervantes Scale is composed of 15 items, punctuated from 0 to 5. This domain ranges from 0 to 75, where 0 corresponds to abscence of physical symptoms, and 75 to the maximum level of physical problems.
Measured: Change from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality.
This domain of the Cervantes Scale is composed of 4 items, punctuated from 0 to 5. This domain ranges from 0 to 20, where 0 corresponds to abscence of sexual problems, and 20 to the maximum level of sexual problems.
Measured: Change from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic.
This domain of the Cervantes Scale is composed of 9 items, punctuated from 0 to 5. This domain ranges from 0 to 45, where 0 corresponds to abscence of anxiety and depression problems, and 45 to the maximum level of anxiety and depression problems.
Measured: Change from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship.
This domain of the Cervantes Scale is composed of 3 items, punctuated from 0 to 5. This domain ranges from 0 to 15, where 0 corresponds to abscence of relationship problems, and 15 to the maximum level of relationship problems.
Measured: Change from baseline, to 3 months and 6 months visit
Cervantes personality scale.
The scale is composed of 20 questions divided in 3 domains. Each question is punctuated from 0 to 5.
First domain is introversion, it is comprised of 7 Items. This domain is punctuated from 0 to 10, where 0 represents a more extroverted personality and 10 more introverted.
Second domain is emotional instability, it is comprised of 7 Items. This domain is punctuated from 0 to 35, where 0 represents more emotional stability and 35 more emotional instability.
Third domain is sincerity, it is comprised of 6 Items. This domain is punctuated from 0 to 30, where 0 represents less sincere and 30 more most sincere.
Measured: Measured at Baseline visit
Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale
The scale is composed of 18 items. Each item is punctuated from 0 to 5. And total scale result ranges from 0 to 90, where 0 corresponds to depression unlikely and more than 54 to severe depression.
Measured: Change from baseline, to 3 months and 6 months visit
Number of adverse events
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Measured: Through the study, an average of 9 months.
Compliance with treatment
Recount of product returned at the 3 months visit and at the 6 months visit of study.
Measured: 6 months
Treatment satisfaction
Treatment satisfaction is measured in three questions valued from 0 to 10, where 0 is considered worst and 10 better. The three questions are about:
- Patient satisfaction with the capsules.
- Patient satisfaction with the results of the treatment.
- Investigator satisfaction with the results of the treatment.
Measured: Measured at the 6 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Apr 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 443 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristo Pharma Iberia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875430
- Sponsor's protocol ID
- ARI-ME-18-01
- Acronym
- OLSEM
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Observational Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT03875430
- Acronym / sponsor ID
- OLSEM / ARI-ME-18-01
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 443 participants (estimated)
- Lead sponsor
- Aristo Pharma IberiaIndustry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Study start
- 15 Apr 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 14 Mar 2019 (actual)
- 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.
This observational study will assess the effects of a dietary supplement based on Humulus Lupulus L. to relieve the symptoms of menopause in perimenopausal and postmenopausal women, by doing a follow up of the Cervantes scale and the Anxiety and depression Goldberg Scale in a period of 6 months. Participants will be allocated to dietary supplement being the difference between groups if they are perimenopausal or postmenopausal, and will attend to 3 visits (baseline, 3 months and 6 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perimenopausal | – | Dietary Supplement: Humulus lupulus LPatients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. |
| Postmenopausal | – | Dietary Supplement: Humulus lupulus LPatients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 40 and 60 years old that attend ginecological consultation in Spain.
Key inclusion criteria (3 listed)
- Perimenopausal according to the Stages of Reproductive Aging Workshop (STRAW) or postmenopausal women between the ages of 40 and 60.
- Having moderate or severe hot flushes.
- Accepting and signing the Informed consent.
Key exclusion criteria (8 listed)
- Women unable to answer the questionnaires.
- Women being treated with sulfonamides, methotrexate, triamterene, sulfasalazine, estrogens, phenytoin, anxiolytics, antidepressants, daily multivitamins, hormonal therapy, use of oral contraceptives in the last 3 months, herbal products to reduce vasomotor symptoms in the last months.
- Women in treatment and control for psychiatric pathology.
- Women with any comorbidity that could be the cause of a symptomatology coinciding but not bound to peri or post-menopause.
- Women diagnosed or with Clinical suspicion of breast cancer, endometrium or other hormone-dependent tumors, genital tract bleeding, actives thromboembolic disorders, active gall bladder illness or being lactose intolerant.
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 |
|---|---|---|
| Humulus lupulus LPatients with this intervention will receive a dietary supplement to relieve the symptoms of menopause | Dietary supplement | Perimenopausal, Postmenopausal |
Primary outcome
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale
Time frame: Change from baseline, to 3 months and 6 months visit
Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health.
Time frame: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 15 items, punctuated from 0 to 5. This domain ranges from 0 to 75, where 0 corresponds to abscence of physical symptoms, and 75 to the maximum level of physical problems.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality.
Time frame: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 4 items, punctuated from 0 to 5. This domain ranges from 0 to 20, where 0 corresponds to abscence of sexual problems, and 20 to the maximum level of sexual problems.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic.
Time frame: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 9 items, punctuated from 0 to 5. This domain ranges from 0 to 45, where 0 corresponds to abscence of anxiety and depression problems, and 45 to the maximum level of anxiety and depression problems.
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship.
Time frame: Change from baseline, to 3 months and 6 months visit
This domain of the Cervantes Scale is composed of 3 items, punctuated from 0 to 5. This domain ranges from 0 to 15, where 0 corresponds to abscence of relationship problems, and 15 to the maximum level of relationship problems.
Cervantes personality scale.
Time frame: Measured at Baseline visit
The scale is composed of 20 questions divided in 3 domains. Each question is punctuated from 0 to 5. First domain is introversion, it is comprised of 7 Items. This domain is punctuated from 0 to 10, where 0 represents a more extroverted personality and 10 more introverted. Second domain is emotional instability, it is comprised of 7 Items. This domain is punctuated from 0 to 35, where 0 represents more emotional stability and 35 more emotional instability. Third domain is sincerity, it is comprised of 6 Items. This domain is punctuated from 0 to 30, where 0 represents less sincere and 30 more most sincere.
Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale
Time frame: Change from baseline, to 3 months and 6 months visit
The scale is composed of 18 items. Each item is punctuated from 0 to 5. And total scale result ranges from 0 to 90, where 0 corresponds to depression unlikely and more than 54 to severe depression.
Number of adverse events
Time frame: Through the study, an average of 9 months.
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Compliance with treatment
Time frame: 6 months
Recount of product returned at the 3 months visit and at the 6 months visit of study.
Treatment satisfaction
Time frame: Measured at the 6 months visit
Treatment satisfaction is measured in three questions valued from 0 to 10, where 0 is considered worst and 10 better. The three questions are about: 1. Patient satisfaction with the capsules. 2. Patient satisfaction with the results of the treatment. 3. Investigator satisfaction with the results of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Aristo Pharma Iberia.
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 8 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 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale (time frame: Change from baseline, to 3 months and 6 months visit). The study lists 10 primary outcomes in all. 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 14 Mar 2019.