Phase
Condition
Menopause
Treatment
Placebo
Gyntima Menopause
Clinical Study ID
Ages 42-60 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoeafor less than 2 years
Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35or 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 habitsduring study
Able to follow study procedures
If perimenopausal, agrees to use an accepted method of contraception for duration ofstudy.
Exclusion
Exclusion Criteria:
History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine orendometrial cancer, breast cancer, or cancers associated with sex hormones
Use of hormonal replacement therapy, hormone analogues, or oral contraceptiveswithin 3 months prior to the start of the study
Intake of herbal or food supplements with known effects on menopause symptoms within 1 month prior to the start of the study. Examples of prohibited substances are blackcohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop [Humulus lupulusL.], soy isoflavones, red clover) within 1 month prior to the start of the study
Use of any food supplement containing probiotics or postbiotics or regularconsumption (>3 days/week) of foods containing probiotics (including yogurt withadded probiotics or bifidus effect) within 1 month prior to the start of the study
Use of oral (>3 days) or parenteral antibiotics within 1 month prior to the start ofthe study
Participants with a new diagnosis of mental health disorder in the last 12 months orwith an unstable or uncontrolled mental health disorder in the opinion of theInvestigator
Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus
Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome
History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreatedor unstable
History of gastrointestinal surgery 6 months prior to the start of the study, withthe exception of appendicectomy
Regular intake (>3 days/week) of medication that affects microbiota or bowelmovements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate)
History of coronary disease, myocardial infarction, unstable angina, or previouscoronary angioplasty
History of venous thromboembolism (VTE) or known to be high risk for VTE due toinherited or acquired thrombophilia (such as factor V Leiden, antiphospholipidsyndrome)
History of stroke or transient ischaemic attack
History of severe renal dysfunction as defined by an estimated glomerular filtrationrate <30 mL/minute or severe liver dysfunction defined as established cirrhosis oractive liver disease with alanine aminotransferase (ALT) >3 × upper limit of normalat baseline
Initiated for new diagnosis or changed dose of UK-approved therapeutic medication ornutraceuticals for a medical condition that can affect study outcomes according tothe Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90days prior to study entry
Diagnosis of primary or secondary immunodeficiency including acquiredimmunodeficiency syndrome, immunodeficiency, or active oncologic disease
Known or suspected alcohol or drug abuse
Any other surgical or medical condition, which in the opinion of the Investigator,may place the participant at higher risk from her participation in the study, or islikely to prevent the participant from complying with the requirements of the studyor completing the study
Currently participating in another study or having participated in one within 3months prior to the start of the study
The participant is pregnant, planning a pregnancy, or breastfeeding
Study Design
Connect with a study center
FutureMeds Glasgow
Glasgow 2648579, Glasgow G20 7BE
United KingdomActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.