Estradiol and Brain Age

International Research Training Group 2804

Status: Completed

Conditions: Estradiol; Estradiol (E2) Vs. Placebo (PLAC)

Treatments: Drug: E2 Valerate; Drug: Placebo

Study type: Observational

Funder types: Other

Identifiers

NCT06773429

E2BrainAge

Details and patient eligibility

About

The ovarian hormone estradiol (E2) is suspected to have a neuroprotective effect on the brain. Further, it is associated with mental health and brain plasticity, function and connectivity. During the menstrual cycle, women experience fluctuation of E2. This is closely associate with neuroplasticity in regions with high estradiol receptor density, such as the hippocampus, anterior cingulate cortex, amygdala, hypothalamus, or the striatum. In the current study we are interested on the effects of E2 on the brain age, indicated by the comparison between the chronological age and the predicted brain age. In a double-blind within-subject study design, naturally cycling females during their follicular menstrual cycle phase (when their endogenous ovarian hormone levels are low) were either administered estradiol valerate (E2) or a placebo (PLAC) to rapidly increase E2 levels independent of other cycling ovarian hormones. Structural brain scans were assessed.

Full description

In this project we assessed regularly cycling females in their early follicular menstrual cycle phase with/without experimentally elevated estradiol (E2) levels in order to examine E2's effect on the brain age. Thus, women were scanned twice in the MR-scanner (E2 vs. PLAC; separated by at least 2-3 months) to deduce underlying structural changes. E2 vs. PLAC were administered in a double-blind, counterbalanced, randomized order. E2 has been administered orally (in total 12mg; two doses à 6mg on two consecutive days). All participants additionally underwent a neuropsychological assessment (demographical data, psychological and clinical data: structured clinical interview, anxiety and depression traits, mood, verbal intelligence, cognitive flexibility, emotion regulation traits, self-esteem). Blood samples were taken to assess endogenous gonadal hormone levels before and after E2/PLAC intake.

Enrollment: 32 patients

Sex: Female

Ages: 19 to 32 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biologically females (assigned sex at birth)
• Regular menstrual cycle lasting between 26 and 35 days
• Right-handedness

Exclusion criteria

• Present or past mental, neurological or endocrine disorders, neurological or head injuries

• Use of hormonal contraceptives during the last six months

• Any other medication intake including intake of antidepressants or neuroleptics

• Past and present pregnancies

• Contraindication for MRI such as:

  • People with non-removable metal objects on or in the body
  • Tattoos if not MRI-incompatible according to expert guidelines
  • Pathological hearing or increased sensitivity to loud noises
  • Claustrophobia
  • Surgery less than three months ago
  • Restricted vision

Trial design

32 participants in 1 patient group

Naturally cycling women

Description:

Naturally cycling women during the early follicular menstrual cycle phase

Treatment:

Drug: Placebo

Drug: E2 Valerate