Status:
UNKNOWN
Study to Investigate the Effectiveness of a Food Supplement Made of Hop in the Improvement of Menopausal Symptoms
Lead Sponsor:
Aristo Pharma Iberia
Collaborating Sponsors:
Analysis and Research Network, S.L
Conditions:
Menopause
Eligibility:
FEMALE
40-60 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2019
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT03875430
Start Date
April 15 2019
End Date
October 30 2019
Last Update
March 14 2019
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