Trial Outcomes & Findings for Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause" (NCT NCT03740009)

Last Updated: 2022-05-10

Results Overview

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 certain tasks require more oxygen to perform the tasks.) is measured while they performed the task in MRI scanner.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 3 weeks

Results posted on

2022-05-10

Participant Flow

The recruitment process included, social media advertising using Facebook, Instagram, and Craigslist; mass emailing using university wide emails and a database of select University of North Carolina (UNC) healthcare patients (Carolina data warehouse); and flyer advertisements placed in university buildings and local businesses

Consented participants complete a screening phase that includes a psychiatric interview and gynecological exam prior to the start of study intervention.

Participant milestones

Participant milestones
Measure	Perimenopausal Women, Depressed Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Overall Study STARTED	20
Overall Study Consented	20
Overall Study Received Intervention	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Perimenopausal Women, Depressed Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Overall Study Physician Decision	9
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perimenopausal Women, Depressed n=20 Participants Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Age, Continuous	49.9 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian, Non-Hispanic	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	1 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian, Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 weeks

Outcome measures

Outcome measures
Measure	Perimenopausal Women, Depressed n=10 Participants Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Caudate Baseline	.0704 percent signal change Standard Deviation .0796
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Caudate Posttreatment	.0475 percent signal change Standard Deviation .0692
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Nucleus Accumbens Baseline	.0623 percent signal change Standard Deviation .0549
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Nucleus Accumbens Posttreatment	.0280 percent signal change Standard Deviation .1166
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Putamen Baseline	.0399 percent signal change Standard Deviation .0459
Change in Frontostriatal Reactivity to Reward During MID fMRI Task Putamen Posttreatment	.0408 percent signal change Standard Deviation .0823

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Perimenopausal Women, Depressed n=10 Participants Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Depressive Symptoms as Measured by the MASQ-AD Baseline Week 1	72.1 score on a scale Standard Deviation 9.7
Depressive Symptoms as Measured by the MASQ-AD Week 2	62.4 score on a scale Standard Deviation 13.24
Depressive Symptoms as Measured by the MASQ-AD Week 3	57.2 score on a scale Standard Deviation 11.57
Depressive Symptoms as Measured by the MASQ-AD Post Treatment Week 4	54.5 score on a scale Standard Deviation 10.83

Adverse Events

Perimenopausal Women, Depressed

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Perimenopausal Women, Depressed n=10 participants at risk Participants will take Bazedoxifene/Conjugated Estrogen orally for 3 weeks Bazedoxifene/Conjugated Estrogen: 20 mg bazedoxifene/0.45mg conjugated estrogens tablets
Endocrine disorders Bloating	30.0% 3/10 • Number of events 3 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Endocrine disorders Hot Flashes	20.0% 2/10 • Number of events 2 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 3 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Nervous system disorders Headache	40.0% 4/10 • Number of events 4 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Reproductive system and breast disorders Cramps	20.0% 2/10 • Number of events 2 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Reproductive system and breast disorders Heavy Menses	20.0% 2/10 • Number of events 2 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Reproductive system and breast disorders Spotting	20.0% 2/10 • Number of events 2 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Endocrine disorders Night Sweats	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Endocrine disorders Appetite Increase	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Gastrointestinal disorders Indigestion	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Ear and labyrinth disorders Increase in Ear Wax	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
General disorders Toothache	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Skin and subcutaneous tissue disorders Poison Ivy Rash	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
General disorders Numbness and Tingling	10.0% 1/10 • Number of events 1 • Adverse event data was tracked from the time participants started the intervention through the end of the protocol (approximately 1 month). All adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.

Additional Information

Crystal Schiller, PhD

UNC School of Medicine

Phone: 919-966-4810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place