Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms

Study Overview
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Brief Summary
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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).

Official Title
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Multicenter Prospective Observational Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms

Conditions
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Menopause

Intervention / Treatment
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* Dietary Supplement: Humulus lupulus L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perimenopausal<br>Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. | Dietary Supplement: Humulus lupulus L<br>* Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause<br>|
| Postmenopausal<br>Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. | Dietary Supplement: Humulus lupulus L<br>* Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 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. | 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 | 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. | 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 at the 6 months visit |