Affect of Duavive on Mood & Anxiety Symptoms

Last updated: November 28, 2024
Sponsor: St. Joseph's Healthcare Hamilton
Overall Status: Active - Recruiting

Phase

1

Condition

Anxiety Disorders

Menopause

Panic Disorders

Treatment

Duavive 0.45Mg-20Mg Tablet

Clinical Study ID

NCT04478305
2019-7333
  • Ages 45-60
  • Female

Study Summary

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

Inclusion

Inclusion Criteria:

  • Females between 45-60 years of age

  • Able to communicate in English

  • In perimenopause as defined by World Health Organization (WHO) Stages ofReproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 yearsof final menstrual period)

  • Suffering from Depressive symptoms (10+ on CES-D-10) AND/OR anxiety symptoms (10+ onGAD-7)

Exclusion

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 thrombophilicdisorders.

  • 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 bloodpressure >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 becorrected 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 beforestudy screening.

  • Known hypersensitivity to either CE or BZA.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Duavive 0.45Mg-20Mg Tablet
Phase: 1
Study Start date:
July 03, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • St Joseph's Healthcare

    Hamilton, Ontario L8P 3B7
    Canada

    Active - Recruiting

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