protocolSection identificationModule nctId: NCT06312033, orgStudyIdInfo id: MRTG_P01, briefTitle: Estradiol's Effect on Brain Volume and Connectivity, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2019-07-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: International Research Training Group 2804, class: OTHER, collaborators name: University Hospital Tübingen, collaborators name: German Research Foundation, collaborators name: Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN), descriptionModule briefSummary: Ovarian hormones are not only modulators of cognitive function, emotion regulation and mental health, but also seem to affect brain plasticity and functional connectivity, During the menstrual cycle, women experience cyclic fluctuation of the ovarian hormone estradiol, which is closely associated with neuroplasticity/changes in brain structure in regions with high estradiol receptor density, such as the amygdala, hippocampus/parahippocampus, anterior cingulate cortex (ACC), striatum, and prefrontal cortex (PFC). Further functional connectivity between these areas seems to be associated with hormonal changes dependent on the menstrual cycle phase. But next to estradiol, also other hormones like progesterone fluctuate across the menstrual cycle. In the past, effects of ovarian hormone levels were often investigated in combination. However, one way to disentangle the impact of estradiol from that of other hormones on neuroplasticity, emotion regulation and mood states, can be the experimental increase of estradiol via estradiol administration. In this double-blinded within-subject study, women were administered either estradiol valerate or placebo during the early follicular phase (thus when ovarian hormone concentrations are low) before undergoing neuroimaging.Parts of the study are already described in Rehbein et al., 2021 and 2022., conditionsModule conditions: Emotion Regulation, conditions: Estradiol, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The intervention assessed the effect of estradiol administration on stress reactivity using a double blind randomized within -between placebo-controled design with repeated measures., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Neither participant or investigator knew the timepoint of drug or placebo administration. Pills were prepared by independent members of the university hospital., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Estradiol Valerate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Impact of E2 concentration on brain structure, primaryOutcomes measure: Impact of E2 concentration and state emotion regulation on brain structure, primaryOutcomes measure: Impact of E2 concentration and emotion regulation traits on brain structure, primaryOutcomes measure: Impact of E2 concentration on resting state functional connectivity, primaryOutcomes measure: Impact of E2 concentration and state emotion regulation on connectivity, primaryOutcomes measure: Impact of E2 concentration and emotion regulation traits on functional connectivity, primaryOutcomes measure: Impact of E2 concentration and associated structural brain changes on connectivity, secondaryOutcomes measure: Impact of E2 concentration and self-esteem on brain structure, secondaryOutcomes measure: Impact of E2 concentration and self-esteem on functional connectivity, secondaryOutcomes measure: Impact of E2 concentration and subjective mood on brain structure, secondaryOutcomes measure: Impact of E2 concentration and state anxiety on brain structure, secondaryOutcomes measure: Impact of E2 concentration and subjective mood on functional connectivity, secondaryOutcomes measure: Impact of E2 concentration and state anxiety on functional connectivity, secondaryOutcomes measure: Impact of E2 administration on E2 concentrations, secondaryOutcomes measure: Impact of E2 administration on E2-progesterone ratio, secondaryOutcomes measure: Impact of E2 administration on testosterone and progesterone concentration, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Tuebingen; Department of Psychiatry & Psychotherapy, city: Tuebingen, state: BW, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False