Clinical trial NCT03875430: Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
Official title: Multicenter Prospective Observational Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menopause
Lead sponsor: Aristo Pharma Iberia
Sponsor class: INDUSTRY
Collaborators: name: Analysis and Research Network, S.L
First posted: 2019-03-14
Enrollment: 443
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women between 40 and 60 years old that attend ginecological consultation in Spain.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health.
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality.
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic.
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship.
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Cervantes personality scale.
timeFrame: Measured at Baseline visit
measure: Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale
timeFrame: Change from baseline, to 3 months and 6 months visit
measure: Number of adverse events
timeFrame: Through the study, an average of 9 months.
measure: Compliance with treatment
timeFrame: 6 months
measure: Treatment satisfaction
timeFrame: Measured at the 6 months visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: