Status:
COMPLETED
Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women
Lead Sponsor:
Nektium Pharma SL
Collaborating Sponsors:
Clínica Barem
Conditions:
Menopause
Dietary Supplements
Eligibility:
FEMALE
45-55 years
Phase:
NA
Brief Summary
This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegra...
Detailed Description
Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled,...
Eligibility Criteria
Inclusion
- Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
- Informed consent to participate in the study.
Exclusion
- Hormone-related pathologies.
- Menopause from surgery origin.
- Family or personal history of endocrine cancer.
- Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise.
- Vegetarian diet or daily consumption of soya rich-products during the last year.
- Anovulatory treatment.
- Hormone replacement treatment.
Key Trial Info
Start Date :
April 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04381026
Start Date
April 19 2017
End Date
July 10 2018
Last Update
May 8 2020
Active Locations (1)
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1
Clinica Barem
Las Palmas de Gran Canaria, Las Palmas (Canary Islands), Spain, 35005