NCT04478305

Affect of Duavive on Mood & Anxiety Symptoms

The Effect of Conjugated Estrogens/ Bazedoxifene (CE/ BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Depression, Anxiety
• Sleep
• Menopause Related Conditions

Interventions

Type	Name	Description
DRUG	Duavive 0.45Mg-20Mg Tablet	Duavee, marketed as Duavive in Canada.

Timeline

• Start date: 2024-07-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-07-20
• Last updated: 2024-12-03

Locations

1 site across 1 country: Canada