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

Aristo Pharma

Status

Unknown

Conditions

Menopause

Treatments

Dietary Supplement: Humulus lupulus L

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03875430

ARI-ME-18-01

Details and patient eligibility

About

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).

Enrollment

443 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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.