Emotion RegulationNCT06312033
Estradiol's Effect on Brain Volume and Connectivity
A study testing Estradiol Valerate in people with Emotion Regulation and Estradiol, run by International Research Training Group 2804 at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Estradiol
- What is being tested?
- Estradiol Valerate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, biologically female (assigned sex at birth)
- regular menstrual cycle lasting between 26 and 32 days
- right handedness
Who cannot join
- present or past mental, neurological or endocrine disorders
- use of hormonal contraceptives during the last six months
- any other medication intake,
- or past and present pregnancies
- Intake of antidepressants or neuroleptics
- contraindication for MRI
Show all 14Show fewer
- 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
- Neurological disease or injury
- Moderate or severe head injury
- Restricted vision
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen; Department of Psychiatry & Psychotherapy
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Estradiol's Effect on Brain Volume and Connectivity in Naturally Cycling Women
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.
Read the detailed description
In this project the investigators wanted to assess women with/without experimentally elevated estradiol (E2) levels in order to understand E2's effect on volume and resting state functional connectivity. Thus, women underwent fMRI (functional magnetic resonance imaging) scanning twice (with/without elevated E2) to deduce underlying neuronal activation. All participants underwent a structured assessment including demographical data, psychological/clinical data, e.g., structured clinical interview, anxiety traits, depression, emotion regulation traits, self-esteem as well as cognitive abilities, e.g., verbal intelligence, cognitive flexibility) and two (f)MRI measurements (T1/T2, separated by at least 2-3 months), including resting-state and anatomical scans as well as a behavioural emotion regulation task. At T1/T2 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 (i.e. leading to an early follicular phase with low ovarian hormone levels) or E2 (i.e. 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 e.g. 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.
- Conditions
- Emotion Regulation, Estradiol
- Being tested
- Estradiol Valerate, Placebo
- Keywords
- brain structure, functional connectivity, sex hormones, women's mental health
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol ValerateDrug
Also called Progynova21
To elevate estradiol levels each woman has received 6mg on two consecutive days (total 12mg) of estradiol valerate (Progynova21©)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| naturally cycling women starting with placebo | Experimental | naturally cycling women during early follicular phase starting with placebo (order was randomly selected) Receives: Drug: Estradiol Valerate; Drug: Placebo |
| naturally cycling women starting with estradiol | Experimental | naturally cycling women during early follicular phase starting with estradiol (order was randomly selected) Receives: Drug: Estradiol Valerate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of E2 concentration on brain structure
Brain structure (assessed via anatomical MRI scans, MPRAGE) will be compared between E2 and placebo conditions in regions of interest (ROI) (including amygdala, hippocampus/parahippocampus, ACC, striatum, and PFC).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and state emotion regulation on brain structure
Brain structure (assessed via anatomical MRI scans, MPRAGE, in cm³) will be compared between E2 and placebo conditions in dependence of state emotion regulation ratings in ROIs (as above). State emotion regulation ratings obtained via the emotion regulation task (subjective rating ranging from -200 to 200).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging (structure) and 20 minutes (emotion regulation task)
Impact of E2 concentration and emotion regulation traits on brain structure
Brain structure (assessed via anatomical MRI scans) will be compared between E2 and placebo conditions in dependence of emotion regulation traits in ROIs (as above). Emotion regulation traits assessed via the Heidelberg Form of Emotion Regulation (HFERST, ranging from 1 to 5) and the Emotion Regulation Questionnaire (ERQ, likert scale 1-7).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration on resting state functional connectivity
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo condition in the whole brain and ROIs (as above).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 concentration and state emotion regulation on connectivity
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo conditions in dependence of emotion regulation ratings in ROIs (as above). State emotion regulation ratings obtained via the emotion regulation task (subjective rating ranging from -200 to 200).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes (connectivity) and 20 minutes (emotion regulation task)
Impact of E2 concentration and emotion regulation traits on functional connectivity
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo conditions in dependence of emotion regulation traits in ROIs (as above). Emotion regulation traits assessed via the Heidelberg Form of Emotion Regulation (HFERST, ranging from 1 to 5) and the Emotion Regulation Questionnaire (ERQ, likert scale 1-7).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes (connectivity) during neuroimaging
Impact of E2 concentration and associated structural brain changes on connectivity
In order to investigate to which degree structural changes in association with E2 concentrations are related to changes in connectivity, both structure and connectivity were assessed via anatomical (MPRAGE) and resting state MRI scans.
Measured: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake (6 minutes structure and 7 minutes connectivity)
Secondary outcomes (9)
Impact of E2 concentration and self-esteem on brain structure
Brain structure (assessed via anatomical MRI scans, MPRAGE) will be compared between E2 and placebo condition on dependence of self-esteem ratings in ROIs (as above). Self-esteem self-ratings assessed via the Rosenberg Self-Esteem Questionnaire (RSQ).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and self-esteem on functional connectivity
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo condition on dependence of self-esteem ratings in ROIs (as above). Self-esteem self-ratings assessed via the Rosenberg Self-Esteem Questionnaire (RSQ).
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 concentration and subjective mood on brain structure
Brain Structure (assessed via anatomical MRI scans, MPRAGE) will be compared between E2 and placebo condition in dependence of subjective mood in ROIs (as above). Ratings of subjective mood/affect obtained on the neuroimaging day.
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and state anxiety on brain structure
Brain Structure (assessed via anatomical MRI scans, MPRAGE) will be compared between E2 and placebo condition in dependence of state anxiety in ROIs (as above). Ratings of state anxiety (State Anxiety Inventory) obtained on the neuroimaging day
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and subjective mood on functional connectivity
Resting state functional connectivity (assessed via resting state MRI) will be compared between E2 and placebo condition in dependence of subjective mood in ROIs (as above). Ratings of subjective mood/affect obtained on the neuroimaging day.
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 concentration and state anxiety on functional connectivity
Resting state functional connectivity (assessed via resting state MRI) will be compared between E2 and placebo condition in dependence of state anxiety in ROIs (as above). Ratings of state anxiety (State Anxiety Inventory) obtained on the neuroimaging day.
Measured: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 administration on E2 concentrations
Changes in E2 concentrations(pmol/L), will be assessed from blood samples before and after pill intake.
Measured: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Impact of E2 administration on E2-progesterone ratio
Changes in E2-progesterone ratio will be assessed from blood samples before and after pill intake.
Measured: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Impact of E2 administration on testosterone and progesterone concentration
Changes in testosterone and progesterone concentrations (nmol/L) will be assessed from blood samples before and after pill intake.
Measured: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Aug 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention assessed the effect of estradiol administration on stress reactivity using a double blind randomized within -between placebo-controled design with repeated measures.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Research Training Group 2804
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN)
- Responsible party
- Sponsor
- Investigators
- Birgit Derntl, Prof., Principal investigator, Departement of Psychiatry & Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312033
- Sponsor's protocol ID
- MRTG_P01
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol's Effect on Brain Volume and Connectivity in Naturally Cycling Women
- ClinicalTrials.gov ID
- NCT06312033
- Acronym / sponsor ID
- MRTG_P01
- Conditions
- Emotion Regulation, Estradiol
- Keywords
- brain structure, functional connectivity, sex hormones, women's mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- International Research Training Group 2804University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this project the investigators wanted to assess women with/without experimentally elevated estradiol (E2) levels in order to understand E2's effect on volume and resting state functional connectivity. Thus, women underwent fMRI (functional magnetic resonance imaging) scanning twice (with/without elevated E2) to deduce underlying neuronal activation. All participants underwent a structured assessment including demographical data, psychological/clinical data, e.g., structured clinical interview, anxiety traits, depression, emotion regulation traits, self-esteem as well as cognitive abilities, e.g., verbal intelligence, cognitive flexibility) and two (f)MRI measurements (T1/T2, separated by at least 2-3 months), including resting-state and anatomical scans as well as a behavioural emotion regulation task. At T1/T2 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 (i.e. leading to an early follicular phase with low ovarian hormone levels) or E2 (i.e. 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 e.g. 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention assessed the effect of estradiol administration on stress reactivity using a double blind randomized within -between placebo-controled design with repeated measures.
| Arm | Type | Receives |
|---|---|---|
| naturally cycling women starting with placebo | Experimental | Drug: Estradiol Valerate, Drug: Placebonaturally cycling women during early follicular phase starting with placebo (order was randomly selected) |
| naturally cycling women starting with estradiol | Experimental | Drug: Estradiol Valerate, Drug: Placebonaturally cycling women during early follicular phase starting with estradiol (order was randomly selected) |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women, biologically female (assigned sex at birth)
- regular menstrual cycle lasting between 26 and 32 days
- right handedness
Key exclusion criteria (14 listed)
- present or past mental, neurological or endocrine disorders
- use of hormonal contraceptives during the last six months
- any other medication intake,
- or past and present pregnancies
- Intake of antidepressants or neuroleptics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol ValerateAlso: Progynova21To elevate estradiol levels each woman has received 6mg on two consecutive days (total 12mg) of estradiol valerate (Progynova21©) | Drug | naturally cycling women starting with estradiol, naturally cycling women starting with placebo |
| PlaceboPlacebo (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) | Drug | naturally cycling women starting with estradiol, naturally cycling women starting with placebo |
Primary outcome
Impact of E2 concentration on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Brain structure (assessed via anatomical MRI scans, MPRAGE) will be compared between E2 and placebo conditions in regions of interest (ROI) (including amygdala, hippocampus/parahippocampus, ACC, striatum, and PFC).
Impact of E2 concentration and state emotion regulation on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging (structure) and 20 minutes (emotion regulation task)
Brain structure (assessed via anatomical MRI scans, MPRAGE, in cm³) will be compared between E2 and placebo conditions in dependence of state emotion regulation ratings in ROIs (as above). State emotion regulation ratings obtained via the emotion regulation task (subjective rating ranging from -200 to 200).
Impact of E2 concentration and emotion regulation traits on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Brain structure (assessed via anatomical MRI scans) will be compared between E2 and placebo conditions in dependence of emotion regulation traits in ROIs (as above). Emotion regulation traits assessed via the Heidelberg Form of Emotion Regulation (HFERST, ranging from 1 to 5) and the Emotion Regulation Questionnaire (ERQ, likert scale 1-7).
Impact of E2 concentration on resting state functional connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo condition in the whole brain and ROIs (as above).
Impact of E2 concentration and state emotion regulation on connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes (connectivity) and 20 minutes (emotion regulation task)
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo conditions in dependence of emotion regulation ratings in ROIs (as above). State emotion regulation ratings obtained via the emotion regulation task (subjective rating ranging from -200 to 200).
Impact of E2 concentration and emotion regulation traits on functional connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes (connectivity) during neuroimaging
Resting state functional connectivity (assessed via resting state fMRI) will be compared between E2 and placebo conditions in dependence of emotion regulation traits in ROIs (as above). Emotion regulation traits assessed via the Heidelberg Form of Emotion Regulation (HFERST, ranging from 1 to 5) and the Emotion Regulation Questionnaire (ERQ, likert scale 1-7).
Impact of E2 concentration and associated structural brain changes on connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake (6 minutes structure and 7 minutes connectivity)
In order to investigate to which degree structural changes in association with E2 concentrations are related to changes in connectivity, both structure and connectivity were assessed via anatomical (MPRAGE) and resting state MRI scans.
9 secondary outcomes
Impact of E2 concentration and self-esteem on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and self-esteem on functional connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 concentration and subjective mood on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and state anxiety on brain structure
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging
Impact of E2 concentration and subjective mood on functional connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 concentration and state anxiety on functional connectivity
Time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 7 minutes during neuroimaging
Impact of E2 administration on E2 concentrations
Time frame: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Impact of E2 administration on E2-progesterone ratio
Time frame: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Impact of E2 administration on testosterone and progesterone concentration
Time frame: From first measurement up to 6 months, with at least two months apart; each time before and after pill intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Derntl, Prof. principal investigator
Departement of Psychiatry & Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol Valerate in people with Emotion Regulation and Estradiol, run by International Research Training Group 2804 at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of E2 concentration on brain structure (time frame: From first measurement up to 6 months, with at least two months apart; each time: approx. 6 minutes during neuroimaging). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.