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

Menopause Clinical Trial

— OLSEM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03875430
• Other study ID #: ARI-ME-18-01
• Status: Not yet recruiting
• Start date: April 15, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: March 2019
• Source: Aristo Pharma Iberia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 443
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Humulus lupulus L
Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristo Pharma Iberia	Analysis and Research Network, S.L

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	Compliance with treatment	Recount of product returned at the 3 months visit and at the 6 months visit of study.	6 months
Primary	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