Estradiol's Effect on Brain Volume and Connectivity

Summary

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.

Conditions

• Emotion Regulation
• Estradiol

Interventions

DRUG

Estradiol Valerate

To elevate estradiol levels each woman has received 6mg on two consecutive days (total 12mg) of estradiol valerate (Progynova21©)

DRUG

Placebo

Placebo (blue-colored hard gelatine capsules completely filled with a mixture of 99.5% mannitol and 0.5% Aerosil (fumed silica)) has been administered (placebo-controlled condition)

Sponsors & Collaborators

• University Hospital Tübingen

  collaborator UNKNOWN

• German Research Foundation

  collaborator OTHER

• Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN)

  collaborator UNKNOWN

• International Research Training Group 2804

  lead OTHER

Principal Investigators

• Birgit Derntl, Prof. · Departement of Psychiatry & Psychotherapy

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2019-07-31

Completion

2021-12-31

Countries

• Germany

Study Locations