NCT03740009: Duavee

Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause"

Completed Phase 4 Results posted Last updated 10 May 2022

What this trial tests

Phase 4 trial testing Bazedoxifene/Conjugated Estrogen in Perimenopausal Disorder in 20 participants. Completed in 17 May 2021.

Timeline

2 January 2019

Primary endpoint
17 May 2021

17 May 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	2 January 2019
Primary completion	17 May 2021
Estimated completion	17 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Bazedoxifene/Conjugated Estrogen — full drug profile →

Conditions studied

• Perimenopausal Disorder — all drugs for Perimenopausal Disorder →
• Depression — all drugs for Depression →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 44 to 55, female only, with Perimenopausal Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Frontostriatal Reactivity to Reward During MID fMRI Task Primary · Baseline to 3 weeks

The primary outcome measure is functional magnetic resonance imaging (fMRI) data collected during a Monetary Incentive Delay (MID) Task. All participants will complete the fMRI Monetary Incentive Delay (MID) task at baseline and at 3 weeks. During the task, participants need to select the correct response during "win" and "lose" conditions by pressing a button on a button box in the MRI. Participant's blood-oxygen-level dependent (BOLD) activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more "active" or involved in cer

Caudate Baseline

Group	Value	95% CI
Perimenopausal Women, Depressed	.0704	± .0796

Caudate Posttreatment

Group	Value	95% CI
Perimenopausal Women, Depressed	.0475	± .0692

Nucleus Accumbens Baseline

Group	Value	95% CI
Perimenopausal Women, Depressed	.0623	± .0549

Nucleus Accumbens Posttreatment

Group	Value	95% CI
Perimenopausal Women, Depressed	.0280	± .1166

Putamen Baseline

Group	Value	95% CI
Perimenopausal Women, Depressed	.0399	± .0459

Putamen Posttreatment

Group	Value	95% CI
Perimenopausal Women, Depressed	.0408	± .0823

Depressive Symptoms as Measured by the MASQ-AD Primary · Baseline, week 2, week 3, week 4 (post treatment)

The second primary outcome measure uses the Mood and Anxiety Symptoms Questionnaire - Anhedonic Depression Scale (MASQ-AD) to examine symptom change. All participants will complete the MASQ-AD at each study visit, which measures their current symptoms of depression and anxiety. Scores range from 22 to 110 with lower scores reflecting a better outcome.

Baseline Week 1

Group	Value	95% CI
Perimenopausal Women, Depressed	72.1	± 9.7

Week 2

Group	Value	95% CI
Perimenopausal Women, Depressed	62.4	± 13.24

Week 3

Group	Value	95% CI
Perimenopausal Women, Depressed	57.2	± 11.57

Post Treatment Week 4

Group	Value	95% CI
Perimenopausal Women, Depressed	54.5	± 10.83

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Perimenopausal Women, Depressed

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (14 terms — click to expand)

Reaction	System	Perimenopausal Women, Depr…
Headache	Nervous system disorders	—
Bloating	Endocrine disorders	—
Nausea	Gastrointestinal disorders	—
Hot Flashes	Endocrine disorders	—
Cramps	Reproductive system and breast disorders	—
Heavy Menses	Reproductive system and breast disorders	—
Spotting	Reproductive system and breast disorders	—
Night Sweats	Endocrine disorders	—
Appetite Increase	Endocrine disorders	—
Indigestion	Gastrointestinal disorders	—
Increase in Ear Wax	Ear and labyrinth disorders	—
Toothache	General disorders	—
Poison Ivy Rash	Skin and subcutaneous tissue disorders	—
Numbness and Tingling	General disorders	—

Data from ClinicalTrials.gov NCT03740009 adverse events section.

Sponsor's own description

Using neuroimaging, the investigator will study the effects of estrogen on mood and brain function in perimenopausal women with depression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Characterizing the spectrum of distress symptoms in midlife women with perimenopausal depression.
   Nathan MD, Bondy E, Prim J, Gibson K, et al · · 2026 · PMID 40912312 · DOI 10.1016/j.jad.2025.120219