Affect of Duavive on Mood & Anxiety Symptoms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorSt. Joseph's Healthcare Hamilton
About this trial
This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.
Eligibility criteria
Qualifiers
Females between 45-60 years of age
Able to communicate in English
In perimenopause as defined by World Health Organization (WHO) Stages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)
Suffering from Depressive symptoms (10+ on CES-D-10) AND/OR anxiety symptoms (10+ on GAD-7)
Disqualifiers
Personal history of breast/ ovarian/ endometrial cancer/ endometrial hyperplasia.
Abnormal uterine bleeding that has not been adequately investigated.
Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).
Active liver disease.
Trial design
Treatments tested in this trial
- Duavive 0.45Mg-20Mg Tablet
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov