Stress vs. ControlNCT06204016
Estradiol and Stress Reactivity in Women
An observational study of Stress vs. Control and Estradiol vs. Placebo, run by International Research Training Group 2804 at 1 site in Germany.
Trial summary
Stress reactivity and prevalence of stress related diseases differ between pre- and postmenopausal women. Thus, hormonal fluctuations may present a general vulnerability factor for stress-related diseases. Especially, the gonadal hormone estradiol (E2) seems to modulate the activity of stress related brain areas. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress vs. Control, Estradiol vs. Placebo
- 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
- 74 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2024to Dec 2025
- Phase
- Observational
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will mainly consist of residents of Tübingen and surrounding areas.
Who may be able to join
- Women, biologically female (assigned sex at birth)
- normal body mass index (18-28 kg/m2)
- Caucasian
- non-smoking
- German language fluency: at least advanced technical college entrance qualification
- Naturally cycling women, older than 18 years with a regular menstrual cycle (25-35 days) and postmenopausal women up to the age of 60 will be included.
Who cannot join
- Neurological or mental disease
- Medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure) as well as venous thromboembolism
- Pregnancy, delivery, and lactation (current and within the last year)
- Any kind of steroid hormonal, pharmacological treatment, or psychotropic treatment in the last three months
- Shift work
- Participants engaging in competitive/extreme sports
Show all 16Show fewer
- Contraindication for MRI
- 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
- Intake of antidepressants or neuroleptics
- Restricted vision
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen; Department of Psychiatry & Psychotherapy
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Associations of Estradiol and Stress Reactivity in Pre- and Postmenopausal Women
Stress reactivity and prevalence of stress related diseases differ between pre- and postmenopausal women. Thus, hormonal fluctuations may present a general vulnerability factor for stress-related diseases. Especially, the gonadal hormone estradiol (E2) seems to modulate the activity of stress related brain areas. The hippocampus and prefrontal areas control the amygdala's response to stress, and E2 may directly modulate the activity, connectivity and structure of these areas. In premenopausal women E2 seems to reduce stress reactivity. However, in postmenopausal women, who no longer produce E2 from the ovaries, E2 seem to increase stress reactivity. With the proposed study the investigators want to directly test E2's modulating effects (disentangled from other gonadal hormones) on stress reactivity of premenopausal women during their early follicular phase, and postmenopausal women by subjecting both groups of women to a psychosocial stress task in a neuroimaging environment.
Read the detailed description
In a double-blinded repeated-measures within-between placebo-controlled design, two groups of women (premenopausal / postmenopausal) will receive either a placebo or estradiol valerate to experimentally increase estradiol (E2) levels. They will further undergo a psychosocial stress task (Montreal Imaging Stress Task) in a neuroimaging environment (functional magnetic resonance imaging - fMRI). By applying a multilevel approach, the investigators will be able to look at stress reactivity from a subjective, sympathetic (heart rate, skin conductance), endocrine (cortisol) and neural perspective. The investigators will further assess how changes in stress reactivity due to E2 increase are associated with gonadal hormones, and changes in neural activity, anatomy and connectivity in pre- compared to postmenopausal women.
At an initial screening session (T0) the investigators will be assessing sociodemographic variables, hand dominance, verbal intelligence, trial making, personality traits, gender identity and roles, childhood trauma, coping styles, sleep, female sexual health, reproductive status, menopausal symptoms, eating behaviour and premenstrual symptoms. After this all women will be invited to the first experimental session (T1, day 1), where blood and hair cortisol samples will be taken, subjective mood will be measured and the first pill treatment administered (placebo or E2 valerate, double-blinded) approx. 24h before the stress induction. They receive a second pill that they should take-in during the next day (T1/day2) approx. 4h before the stress induction. On T1/day 2 in the afternoon, participants come to the laboratory where the experimental procedure takes place. Participants will again be screened for MRI-exclusion criteria and after ensuring that all requirements are met to go into the MR-scanner, participants will be prepared (application of sensor for pulsoxymetry and electrodes for skin conductance assessment) and moved into the scanner, where they will undergo the stress induction via the Montreal Imaging Stress Task (MIST), a resting state scan, an anatomical scan and a diffusion tensor imaging (DTI) measurement. Throughout the MR-session, pulsoxymetry and skin conductance will constantly be assessed. Mood, subjective affect and stress, and saliva samples for further cortisol analyses will be taken at six time points throughout the experimental session. Furthermore, subjective variables on stress, self-esteem, emotion regulation, positive and negative affect, emotional self-rating, resting state, mental health, depression and anxiety scores and side effects of E2 intake will be assessed. A blood sample will be drawn (30ml) by medically trained personnel during the experimental session. For seven days following the experimental session, participants will give daily information on subjective experiences via an ecological momentary assessment (EMA). Then, the second experimental session (T2) will be scheduled at least two menstrual cycles (naturally cycling women) or 2 months (postmenopausal women) after the first experimental session (T1). For naturally cycling women, both experimental sessions will be scheduled up to 5 days after onset of menses. Naturally cycling women are asked to report the onset of their next menses after the experimental session. The procedure of the second experimental session (T2) will be similar to that of T1.
- Conditions
- Stress vs. Control, Estradiol vs. Placebo
- Being tested
- Estradiol Valerate, Placebo
- Keywords
- stress reactivity, mood homeostasis, neuroimaging (fMRI), menopause, menstrual cycle, sex hormones, women's mental health, estradiol
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 will receive 12mg on two consecutive days (total 24mg) of estradiol valerate (Progynova21©)
PlaceboDrug
Also called P-Tabletten
Placebo tablets will be administered as placebo-controlled condition (P-Tabletten White 7mm, Lichtenstein)
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women | naturally cycling women without hormonal contraception Receives: Drug: Estradiol Valerate; Drug: Placebo | |
| postmenopausal women | women after menopause (min. 12 months no menstrual bleeding) Receives: Drug: Estradiol Valerate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between elevated E2 concentration and acute stress effects on subjective experience
Ratings of positive and negative affect as well as stress, before and after stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset, just before stress onset, immediately after stress, approx. 40 minutes, 60 minutes and 120 minutes after stress onset
Associations of E2 and acute stress effects on Hypothalamic-Pituitary-Adrenal-axis (HPA) response
Cortisol saliva samples before and after the stress task as indicator of stress/HPA-axis activation. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset, just before stress onset, immediately after stress, approx. 40 minutes, 60 minutes and 120 minutes after stress onset
Association between E2 concentration and acute stress induced effects on neural level.
Variability in activity of the brains stress network will be quantified using fMRI to assess differences between stress vs. control conditions during the stress task. Changes in activity will be assessed within regions associated with stress reactivity and regulation (amygdala, hippocampus, prefrontal cortex, anterior cingulate cortex (ACC), middle frontal gyrus (MFG), right superior temporal gyrus (STG), insula, striatum and praecuneus). Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice three months apart; each time: approx. 5 minutes during neuroimaging
Association between E2 concentration and brain volume changes
Via structural MRI scans changes in brain volume following E2 administration compared to placebo will be assessed, especially for the following brain regions: amygdala, hippocampus, prefrontal cortex (including orbito frontal cortex), anterior cingulate cortex (ACC), insula, middle frontal gyrus (MFG), right superior temporal gyrus (STG), fusiform gyrus, thalamus, cerebellum and inferior parietal lobule (IPL). Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two- three months apart; each time: approx. 10 minutes during neuroimaging
Association between E2 concentration and connectivity (resting state) changes
Via a resting state scan, effects of estradiol concentration compared to placebo administration on connectivity changes will be assessed by applying whole brain network (especially Default Mode, Dorsal Attention, Frontoparietal, and Limbic networks) and region of interest analysis (especially of the amygdala, middle temporal gyrus (MTG), inferior frontal gyrus (IFG), postcentral gyrus, striatum, insula and ventrolateral, dorsolateral and medial prefrontal cortex (PFC), fusiform gyrus and anterior cingulate gyrus (ACC)). Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: approx. 10 minutes during neuroimaging
Changes in hormonal levels induced by increased E2 concentration.
Changes in E2 levels (pmol/L) will be assessed from blood samples before and after pill intake (placebo or estradiol valerate) and stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; pill intake a day before and on the day of neuroimaging
Changes in hormonal levels induced by increased E2 concentration.
Changes in progesterone, testosterone, and allopregnanolone levels (nmol/L) will be assessed from blood samples before and after pill intake (placebo or estradiol valerate) and stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; pill intake a day before and on the day of neuroimaging
Secondary outcomes (5)
Associations between E2 concentration and acute stress effects on physiological responses.
Measurements of heart rate and skin conductance as indicators of stress during fMRI. Comparing E2 against placebo in pre- and postmenopausal women. Comparing placebo against estradiol as well as pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: 20 minutes during the fMRI stress task
Association between E2 concentration and chronic stress
Associations of chronic stress, assessed via hair cortisol measures and chronic stress questionnaire (Trier Inventar of Chronic Stress - TICS; value range = [0 228]; higher outcome relates to a higher chronic stress rating), with estradiol and stress reactivity. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart
Association between E2 concentration and effects on aftermath of stress.
To assess the subjective experience during the period following stress induction,an ecological momentary assessement EMA (7 days) will be obtained. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time for 7days
Associations between elevated E2 concentration and acute stress effects on subjective experience
Ratings of self-esteem before and after stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset and120 minutes after stress onset
Associations between elevated E2 concentration and acute stress effects on subjective experience
Ratings of state anxiety before and after stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Measured: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset and120 minutes after stress onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start7 Mar 2024
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress vs. ControlStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Research Training Group 2804
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Birgit Derntl, Prof., Principal investigator, Departement of Psychiatry & Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204016
- Sponsor's protocol ID
- IRTG_P02
- Status last verified
- Mar 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication and finishing the study, anonymized research data cab be available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Estradiol and Stress Reactivity in Pre- and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06204016
- Acronym / sponsor ID
- IRTG_P02
- Conditions
- Stress vs. Control, Estradiol vs. Placebo
- Keywords
- stress reactivity, mood homeostasis, neuroimaging (fMRI), menopause, menstrual cycle, sex hormones, women's mental health, estradiol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- International Research Training Group 2804University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Uppsala University
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jan 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.
Stress reactivity and prevalence of stress related diseases differ between pre- and postmenopausal women. Thus, hormonal fluctuations may present a general vulnerability factor for stress-related diseases. Especially, the gonadal hormone estradiol (E2) seems to modulate the activity of stress related brain areas. The hippocampus and prefrontal areas control the amygdala's response to stress, and E2 may directly modulate the activity, connectivity and structure of these areas. In premenopausal women E2 seems to reduce stress reactivity. However, in postmenopausal women, who no longer produce E2 from the ovaries, E2 seem to increase stress reactivity. With the proposed study the investigators want to directly test E2's modulating effects (disentangled from other gonadal hormones) on stress reactivity of premenopausal women during their early follicular phase, and postmenopausal women by subjecting both groups of women to a psychosocial stress task in a neuroimaging environment.
Detailed description
In a double-blinded repeated-measures within-between placebo-controlled design, two groups of women (premenopausal / postmenopausal) will receive either a placebo or estradiol valerate to experimentally increase estradiol (E2) levels. They will further undergo a psychosocial stress task (Montreal Imaging Stress Task) in a neuroimaging environment (functional magnetic resonance imaging - fMRI). By applying a multilevel approach, the investigators will be able to look at stress reactivity from a subjective, sympathetic (heart rate, skin conductance), endocrine (cortisol) and neural perspective. The investigators will further assess how changes in stress reactivity due to E2 increase are associated with gonadal hormones, and changes in neural activity, anatomy and connectivity in pre- compared to postmenopausal women.
At an initial screening session (T0) the investigators will be assessing sociodemographic variables, hand dominance, verbal intelligence, trial making, personality traits, gender identity and roles, childhood trauma, coping styles, sleep, female sexual health, reproductive status, menopausal symptoms, eating behaviour and premenstrual symptoms. After this all women will be invited to the first experimental session (T1, day 1), where blood and hair cortisol samples will be taken, subjective mood will be measured and the first pill treatment administered (placebo or E2 valerate, double-blinded) approx. 24h before the stress induction. They receive a second pill that they should take-in during the next day (T1/day2) approx. 4h before the stress induction. On T1/day 2 in the afternoon, participants come to the laboratory where the experimental procedure takes place. Participants will again be screened for MRI-exclusion criteria and after ensuring that all requirements are met to go into the MR-scanner, participants will be prepared (application of sensor for pulsoxymetry and electrodes for skin conductance assessment) and moved into the scanner, where they will undergo the stress induction via the Montreal Imaging Stress Task (MIST), a resting state scan, an anatomical scan and a diffusion tensor imaging (DTI) measurement. Throughout the MR-session, pulsoxymetry and skin conductance will constantly be assessed. Mood, subjective affect and stress, and saliva samples for further cortisol analyses will be taken at six time points throughout the experimental session. Furthermore, subjective variables on stress, self-esteem, emotion regulation, positive and negative affect, emotional self-rating, resting state, mental health, depression and anxiety scores and side effects of E2 intake will be assessed. A blood sample will be drawn (30ml) by medically trained personnel during the experimental session. For seven days following the experimental session, participants will give daily information on subjective experiences via an ecological momentary assessment (EMA). Then, the second experimental session (T2) will be scheduled at least two menstrual cycles (naturally cycling women) or 2 months (postmenopausal women) after the first experimental session (T1). For naturally cycling women, both experimental sessions will be scheduled up to 5 days after onset of menses. Naturally cycling women are asked to report the onset of their next menses after the experimental session. The procedure of the second experimental session (T2) will be similar to that of T1.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenopausal women | – | Drug: Estradiol Valerate, Drug: Placebonaturally cycling women without hormonal contraception |
| postmenopausal women | – | Drug: Estradiol Valerate, Drug: Placebowomen after menopause (min. 12 months no menstrual bleeding) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will mainly consist of residents of Tübingen and surrounding areas.
Key inclusion criteria (6 listed)
- Women, biologically female (assigned sex at birth)
- normal body mass index (18-28 kg/m2)
- Caucasian
- non-smoking
- German language fluency: at least advanced technical college entrance qualification
Key exclusion criteria (16 listed)
- Neurological or mental disease
- Medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure) as well as venous thromboembolism
- Pregnancy, delivery, and lactation (current and within the last year)
- Any kind of steroid hormonal, pharmacological treatment, or psychotropic treatment in the last three months
- Shift work
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 will receive 12mg on two consecutive days (total 24mg) of estradiol valerate (Progynova21©) | Drug | postmenopausal women, premenopausal women |
| PlaceboAlso: P-TablettenPlacebo tablets will be administered as placebo-controlled condition (P-Tabletten White 7mm, Lichtenstein) | Drug | postmenopausal women, premenopausal women |
Primary outcome
Associations between elevated E2 concentration and acute stress effects on subjective experience
Time frame: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset, just before stress onset, immediately after stress, approx. 40 minutes, 60 minutes and 120 minutes after stress onset
Ratings of positive and negative affect as well as stress, before and after stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Associations of E2 and acute stress effects on Hypothalamic-Pituitary-Adrenal-axis (HPA) response
Time frame: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset, just before stress onset, immediately after stress, approx. 40 minutes, 60 minutes and 120 minutes after stress onset
Cortisol saliva samples before and after the stress task as indicator of stress/HPA-axis activation. Comparing E2 against placebo in pre- and postmenopausal women.
Association between E2 concentration and acute stress induced effects on neural level.
Time frame: Measured twice three months apart; each time: approx. 5 minutes during neuroimaging
Variability in activity of the brains stress network will be quantified using fMRI to assess differences between stress vs. control conditions during the stress task. Changes in activity will be assessed within regions associated with stress reactivity and regulation (amygdala, hippocampus, prefrontal cortex, anterior cingulate cortex (ACC), middle frontal gyrus (MFG), right superior temporal gyrus (STG), insula, striatum and praecuneus). Comparing E2 against placebo in pre- and postmenopausal women.
Association between E2 concentration and brain volume changes
Time frame: Measured twice two- three months apart; each time: approx. 10 minutes during neuroimaging
Via structural MRI scans changes in brain volume following E2 administration compared to placebo will be assessed, especially for the following brain regions: amygdala, hippocampus, prefrontal cortex (including orbito frontal cortex), anterior cingulate cortex (ACC), insula, middle frontal gyrus (MFG), right superior temporal gyrus (STG), fusiform gyrus, thalamus, cerebellum and inferior parietal lobule (IPL). Comparing E2 against placebo in pre- and postmenopausal women.
Association between E2 concentration and connectivity (resting state) changes
Time frame: Measured twice two-three months apart; each time: approx. 10 minutes during neuroimaging
Via a resting state scan, effects of estradiol concentration compared to placebo administration on connectivity changes will be assessed by applying whole brain network (especially Default Mode, Dorsal Attention, Frontoparietal, and Limbic networks) and region of interest analysis (especially of the amygdala, middle temporal gyrus (MTG), inferior frontal gyrus (IFG), postcentral gyrus, striatum, insula and ventrolateral, dorsolateral and medial prefrontal cortex (PFC), fusiform gyrus and anterior cingulate gyrus (ACC)). Comparing E2 against placebo in pre- and postmenopausal women.
Changes in hormonal levels induced by increased E2 concentration.
Time frame: Measured twice two-three months apart; pill intake a day before and on the day of neuroimaging
Changes in E2 levels (pmol/L) will be assessed from blood samples before and after pill intake (placebo or estradiol valerate) and stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
Changes in hormonal levels induced by increased E2 concentration.
Time frame: Measured twice two-three months apart; pill intake a day before and on the day of neuroimaging
Changes in progesterone, testosterone, and allopregnanolone levels (nmol/L) will be assessed from blood samples before and after pill intake (placebo or estradiol valerate) and stress induction. Comparing E2 against placebo in pre- and postmenopausal women.
5 secondary outcomes
Associations between E2 concentration and acute stress effects on physiological responses.
Time frame: Measured twice two-three months apart; each time: 20 minutes during the fMRI stress task
Association between E2 concentration and chronic stress
Time frame: Measured twice two-three months apart
Association between E2 concentration and effects on aftermath of stress.
Time frame: Measured twice two-three months apart; each time for 7days
Associations between elevated E2 concentration and acute stress effects on subjective experience
Time frame: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset and120 minutes after stress onset
Associations between elevated E2 concentration and acute stress effects on subjective experience
Time frame: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset and120 minutes after stress onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Yes. After publication and finishing the study, anonymized research data cab be available.
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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?
An observational study of Stress vs. Control and Estradiol vs. Placebo, 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Derntl, Prof. (0049 07071 2985437, birgit.derntl@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between elevated E2 concentration and acute stress effects on subjective experience (time frame: Measured twice two-three months apart; each time: approx. 45 minutes before stress onset, just before stress onset, immediately after stress, approx. 40 minutes, 60 minutes and 120 minutes after stress onset). 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 8 Mar 2024.