Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312033
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-02-06
Brief Title:
Estradiols Effect on Brain Volume and Connectivity
Sponsor:
International Research Training Group 2804
Organization:
International Research Training Group 2804
Study Overview
Official Title:
Estradiols Effect on Brain Volume and Connectivity in Naturally Cycling Women
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 neuroplasticitychanges in brain structure in regions with high estradiol receptor density such as the amygdala hippocampusparahippocampus 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
Parts of the study are already described in Rehbein et al 2021 and 2022
Detailed Description:
In this project the investigators wanted to assess women withwithout experimentally elevated estradiol E2 levels in order to understand E2s effect on volume and resting state functional connectivity Thus women underwent fMRI functional magnetic resonance imaging scanning twice withwithout elevated E2 to deduce underlying neuronal activation All participants underwent a structured assessment including demographical data psychologicalclinical data eg structured clinical interview anxiety traits depression emotion regulation traits self-esteem as well as cognitive abilities eg verbal intelligence cognitive flexibility and two fMRI measurements T1T2 separated by at least 2-3 months including resting-state and anatomical scans as well as a behavioural emotion regulation task At T1T2 either E2 valerate or placebo was administered in a double-blinded counterbalanced randomized order
E2 valerate administration To experimentally elevate E2 concentrations each woman has received 6mg on two consecutive days total 12mg of E2 valerate Progynova21 Administration of E2 has been randomly distributed so that women either received placebo ie leading to an early follicular phase with low ovarian hormone levels or E2 ie leading to an early follicular phase with high E2 levels first Functional resting-state and anatomical data emotion regulation performance state anxiety mood and depression scores have been acquired after the second pill intake During the emotion regulation task women were asked to either a passively view aversive pictures or b down regulate their emotional response by eg changing their perspective on the picture and then rate their emotional state
To assess changes in hormone concentrations E2 progesterone testosterone blood samples were obtained before the first and after the second pill intake
E2 valerate administration To experimentally elevate E2 concentrations each woman has received 6mg on two consecutive days total 12mg of E2 valerate Progynova21 Administration of E2 has been randomly distributed so that women either received placebo ie leading to an early follicular phase with low ovarian hormone levels or E2 ie leading to an early follicular phase with high E2 levels first Functional resting-state and anatomical data emotion regulation performance state anxiety mood and depression scores have been acquired after the second pill intake During the emotion regulation task women were asked to either a passively view aversive pictures or b down regulate their emotional response by eg changing their perspective on the picture and then rate their emotional state
To assess changes in hormone concentrations E2 progesterone testosterone blood samples were obtained before the first and after the second pill intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None