CI

At a glance

ClinicalIndex Comparison Record
Phase 4Recruiting· 103 target
Drug / intervention
Transdermal Estradiol +3 moredrug
Likely dose
Transdermal Estradiol 100μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05282277
NCT05282277Phase 4RecruitingOn TrackUpdated 2mo ago
Long Recruiting
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Examining the Effects of Estradiol on Neural and Molecular Response to Rewards in Perimenopausal-Onset Anhedonia and Psychosis

University of North Carolina, Chapel Hill·interventional·Posted Mar 16, 2022·Updated Apr 29, 2026

In Brief

A Phase 4 clinical trial evaluating Transdermal Estradiol, Micronized Progesterone, and 2 other interventions for Depression and 2 related conditions. Currently recruiting, targeting 103 participants across 1 site.

Detailed Summary

This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Psychosis, Anhedonia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4Recruiting
20232024202520262027
First PostedMar 16, 2022
Enrollment StartApr 20, 2022
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 4.3 years agoPrimary completion in 6 months

Interventions

Transdermal Estradioldrug

Participants will be randomized to receive transdermal estradiol (100μg/day) patch for 3 weeks.

Micronized Progesteronedrug

Participants will receive an additional week of micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Matching Placebo Patchdrug

Participants will be randomized to receive a transdermal estradiol-matching placebo patch for 3 weeks

Raclopride C11drug

All Participants will receive two PET-MR scans using \[11C\]raclopride IV as the tracer. The first scan will occur at baseline and the second at post treatment after 3 weeks.