Examining the Effects of Estradiol on Neural and Molecular Response to Reward
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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).
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause transition (Stages of Reproductive Aging Workshop (STRAW stage -1).
Anhedonia or psychosis symptoms that began during the period of menstrual irregularity.
Disqualifiers
Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.
BMI < 18 or > 35 kg/m²
A history of chronic menstrual cycle irregularity, meaning > 1 year without menses
MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100% plastic.
Trial design
Treatments tested in this trial
- Transdermal Estradiol
- Micronized Progesterone
- Matching Placebo Patch
- Raclopride C11
Treatment groups
103 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov