Estradiol and Brain Age

NCT ID: NCT06773429

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-07-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Naturally cycling women

Naturally cycling women during the early follicular menstrual cycle phase

E2 Valerate

Intervention Type: DRUG

To experimentally elevate E2 levels females received 6mg of E2 valerate (Progynova21©) on two consecutive days (in total 12mg).

Placebo

Intervention Type: DRUG

Placebo pills (blue-colored hard gelatine capsules filled with a mixture of 99.5% mannitol and 0.5% Aerosil (fumed silica)) have been administered for the placebo-controlled condition.

Interventions

E2 Valerate

To experimentally elevate E2 levels females received 6mg of E2 valerate (Progynova21©) on two consecutive days (in total 12mg).

Intervention Type: DRUG

Placebo

Placebo pills (blue-colored hard gelatine capsules filled with a mixture of 99.5% mannitol and 0.5% Aerosil (fumed silica)) have been administered for the placebo-controlled condition.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tübingen

UNKNOWN

Sponsor Role: collaborator

DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)

UNKNOWN

Sponsor Role: collaborator

Mini Research Training Group (MRTG)

UNKNOWN

Sponsor Role: collaborator

International Research Training Group 2804

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgit Derntl, Prof.

Role: PRINCIPAL_INVESTIGATOR

Departement of Psychiatry & Psychotherapy

Locations

University of Tuebingen; Department of Psychiatry & Psychotherapy

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

E2BrainAge

Identifier Type: -

Identifier Source: org_study_id