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

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

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).

Study Overview

• Status: Unknown
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: Humulus lupulus L

• Study Type: Observational
• Enrollment (Anticipated): 443

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women between 40 and 60 years old that attend ginecological consultation in Spain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perimenopausal; Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L.	Dietary supplement: Humulus lupulus L; 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.	Dietary supplement: Humulus lupulus L; Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale	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 from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health.	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 from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality.	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 from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic.	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 from baseline, to 3 months and 6 months visit
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship.	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.	Change from baseline, to 3 months and 6 months visit
Cervantes personality scale.	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.	Measured at Baseline visit
Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale	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.	Change from baseline, to 3 months and 6 months visit
Number of adverse events	Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product	Through the study, an average of 9 months.
Compliance with treatment	Recount of product returned at the 3 months visit and at the 6 months visit of study.	6 months
Treatment satisfaction	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: Patient satisfaction with the capsules.; Patient satisfaction with the results of the treatment.; Investigator satisfaction with the results of the treatment.	Measured at the 6 months visit

Collaborators and Investigators

• Sponsor: Aristo Pharma Iberia
• Collaborators: Analysis and Research Network, S.L

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2019
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ARI-ME-18-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No