Recruiting
Phase 1

Duavive

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04478305

Conditions

Menopause

Depression, Anxiety

Sleep

Menopause Related Conditions

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Interventions

Duavive 0.45Mg-20Mg Tablet

Study Details

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.

Conditions

Menopause

Depression, Anxiety

Sleep

Menopause Related Conditions

Study ID

NCT04478305

Start date

Jul 3, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention group

Patient will be provided with study medication. To be taken once a day for 16 weeks (112 days). Active drug brand name - Duavive/Duavee. Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.

Interventions

Duavive 0.45Mg-20Mg Tablet

Duavee, marketed as Duavive in Canada.

Primary outcome measure

  • Depressive symptoms [ Time Frame: At 4 weeks weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 8 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 12 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 16 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 4 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 8 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 12 weeks after beginning study ]
  • Depressive symptoms [ Time Frame: At 16 weeks after beginning study ]
  • Anxiety symptoms [ Time Frame: At 4 weeks after beginning study ]
  • Anxiety symptoms [ Time Frame: At 8 weeks after beginning study ]
  • Anxiety symptoms [ Time Frame: At 12 weeks after beginning study ]
  • Anxiety symptoms [ Time Frame: At 16 weeks after beginning study ]

Central Contacts and Locations

Central contacts

Alison Shea, MD

905-521-2100ashea@stjosham.on.ca

Leticia Hernandez Galan, PhD

2897001324lgalan@stjosham.on.ca

Locations

St Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8P 3B7

Contacts

Leticia Hernandez Galan, PhD

2897001324lgalan@stjosham.on.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Dec 3, 2024

Last verified

Nov, 2024

Keywords

  • hormone replacement therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2024-12-03.