Menopause study: Duavive
Official title Affect of Duavive on Mood & Anxiety Symptoms
ClinicalTrials.gov ID: NCT04478305
What this study is testing
What is Duavive 0.45Mg-20Mg Tablet?
an investigational oral tablet being studied as a potential treatment for depression, anxiety, and sleep problems in peri‑ and early‑postmenopausal women is designed to combine conjugated estrogens, which provide estrogen activity, with bazedoxifene, a selective estrogen receptor modulator that blocks estrogen effects in certain tissues
Also referred to as Duavee.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether Duavive can improve depression and anxiety symptoms in women going through menopause.
- Who it's for
- Women who are in the peri‑menopausal or early menopausal stage.
- What's involved
- Participants will take the Duavive medication and complete mood questionnaires and other study visits.
- Phase 1: an early, usually small safety study
- Time commitment: about 16 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 60, women only
You may be able to join if
- 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...
- Suffering from Depressive symptoms (10+ on CES-D-10) AND/OR anxiety symptoms (10+ on GAD-7)
You likely can't join if
- 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...
- Active liver disease.
- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
- Known or suspected pregnancy, women who may become pregnant, and nursing mothers
See the full eligibility criteria
- 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)
- 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.
- Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.
- Known or suspected pregnancy, women who may become pregnant, and nursing mothers
- Partial or complete loss of vision due to ophthalmic vascular disease.
- Uncontrolled hypertension (Systolic blood pressure \>160mm Hg and/ or diastolic blood pressure \>95 mm Hg)
- Endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., Cushing's disease, Addison's disease). For women with abnormal TSH, it will be corrected in advance of trial initiation.
- Active serious suicidal ideation with intent.
- Symptoms of active psychosis.
- Daily use of antidepressive medication.
- Use of other psychoactive or centrally acting medications within 2 weeks before study screening.
- Known hypersensitivity to either CE or BZA.
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 45 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.