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

NCT ID: NCT03875430

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 443 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-10-30

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).

Conditions

Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Perimenopausal

Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L.

Humulus lupulus L

Intervention Type: DIETARY_SUPPLEMENT

Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause

Postmenopausal

Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L.

Humulus lupulus L

Intervention Type: DIETARY_SUPPLEMENT

Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause

Interventions

Humulus lupulus L

Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Analysis and Research Network, S.L

OTHER

Sponsor Role: collaborator

Aristo Pharma Iberia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ARI-ME-18-01

Identifier Type: -

Identifier Source: org_study_id