Clinical trial NCT04478305: Affect of Duavive on Mood & Anxiety Symptoms
Official title: The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Menopause
Depression, Anxiety
Sleep
Menopause Related Conditions
Keywords: hormone replacement therapy
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Pfizer
First posted: 2020-07-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group longitudinal study
Primary purpose: TREATMENT

Brief summary: This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

Detailed description: During the transition to menopause, women are at risk for developing symptoms of depression and anxiety, and impaired sleep. Fluctuation in estrogen levels appears to play a role in this. The investigators suspect that the administration of estrogens without progesterone, such as conjugated estrogens/ bazedoxifene (CE/ BZA), may improve mood symptoms in this population. In 2017, CE/ BZA was approved for menopausal vasomotor symptoms (VMS) in Canada, but the effect on mood were not examined closely.

The investigators propose a pilot study of 30 peri- and early postmenopausal women, currently seeking treatment for symptoms of depression or anxiety. The participants will go through a round of treatment with CE/BZA. The study will last 16 weeks. The study's objectives are to determine primarily if CE/BZA improves mood among peri- and early postmenopausal women, and secondarily if treatment with CE/BZA improves their sleep.

Eligibility criteria: Inclusion 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: At 4 weeks weeks after beginning study
measure: Depressive symptoms
timeFrame: At 8 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 12 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 16 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 4 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 8 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 12 weeks after beginning study
measure: Depressive symptoms
timeFrame: At 16 weeks after beginning study
measure: Anxiety symptoms
timeFrame: At 4 weeks after beginning study
measure: Anxiety symptoms
timeFrame: At 8 weeks after beginning study
measure: Anxiety symptoms
timeFrame: At 12 weeks after beginning study
measure: Anxiety symptoms
timeFrame: At 16 weeks after beginning study
Secondary outcomes:
measure: Menopause symptoms
timeFrame: At 4 weeks after beginning study
measure: Menopause symptoms
timeFrame: At 8 weeks after beginning study
measure: Menopause symptoms
timeFrame: At 12 weeks after beginning study
measure: Menopause symptoms
timeFrame: At 16 weeks after beginning study
measure: Total nightly sleep time
timeFrame: At 4 weeks after beginning study
measure: Total nightly sleep time
timeFrame: At 8 weeks after beginning study
measure: Total nightly sleep time
timeFrame: At 12 weeks after beginning study
measure: Total nightly sleep time
timeFrame: At 16 weeks after beginning study
measure: Sleep onset latency
timeFrame: At 4 weeks after beginning study
measure: Sleep onset latency
timeFrame: At 8 weeks after beginning study
measure: Sleep onset latency
timeFrame: At 12 weeks after beginning study
measure: Sleep onset latency
timeFrame: At 16 weeks after beginning study
measure: Wake after sleep onset
timeFrame: At 4 weeks after beginning study
measure: Wake after sleep onset
timeFrame: At 8 weeks after beginning study
measure: Wake after sleep onset
timeFrame: At 12 weeks after beginning study
measure: Wake after sleep onset
timeFrame: At 16 weeks after beginning study
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare, McMaster University
name: Alison Shea, MD
role: PRINCIPAL_INVESTIGATOR
References: