Menopause Clinical Trials

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Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this study, we want to investigate if the active product consisting of a probiotic blend can potentiate the recirculation of active oestrogens into the bloodstream and help to mitigate menopause symptoms, which are closely related to oestrogens levels

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 42
Maximum Age: 60
Healthy Volunteers: f
View:

• Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoea for less than 2 years

• Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35 or more per week recorded daily for 14 consecutive days)

• BMI between 18.5 and 34.9 kg/m2

• Menopause rating score II (MRS-II) total score of 9 or more at baseline visit

• Willing to sign Informed Consent Form

• Willing to not make relevant changes to their current dietary or lifestyle habits during study

• Able to follow study procedures

• If perimenopausal, agrees to use an accepted method of contraception for duration of study.

Locations
Other Locations
United Kingdom
FutureMeds Glasgow
RECRUITING
Glasgow
Contact Information
Primary
Kristen Laing, MBChB
kristen.laing@futuremeds.com
0141 946 7888
Backup
David Cogan
david.cogan@futuremeds.com
0141 946 7888
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-10-25
Participants
Target number of participants: 140
Treatments
Experimental: Gyntima Menopause
Study treatment
Placebo_comparator: Placebo
Placebo comparator arm
Related Therapeutic Areas
Sponsors
Leads: Community Pharmacology Services Ltd
Collaborators: Kaneka Americas Holding Inc.

This content was sourced from clinicaltrials.gov