Menopause
Conditions
Brief 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. 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).
Interventions
DIETARY_SUPPLEMENTHumulus lupulus L
Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause
Sponsors
Analysis and Research Network, S.L
Aristo Pharma Iberia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 6 months | Recount of product returned at the 3 months visit and at the 6 months visit of study. |
| Treatment satisfaction | 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. |
Outcome results
None listed