Effects of Estradiol on Stress Reactivity in Women
Associations of Estradiol and Stress Reactivity in Pre- and Postmenopausal Women
This study is testing if taking estradiol can change how premenopausal and postmenopausal women react to stress compared to those who take a placebo.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | International Research Training Group 2804 Academic / other |
| Locations | 1 site (Tuebingen, BW) |
| Trial ID | NCT06204016 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how estradiol influences stress reactivity in premenopausal and postmenopausal women. Participants will receive either estradiol valerate or a placebo and undergo a psychosocial stress task while being monitored with functional magnetic resonance imaging (fMRI). The study aims to assess changes in stress responses from subjective, physiological, and neural perspectives, focusing on the role of estradiol in modulating stress-related brain activity. By comparing the two groups, the researchers hope to clarify the hormonal effects on stress reactivity across different life stages.
Who should consider this trial
Good fit: Ideal candidates include biologically female individuals aged 18-60, either premenopausal with regular menstrual cycles or postmenopausal, who meet specific health criteria.
Not a fit: Patients with neurological or mental diseases, chronic medical conditions, or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of stress-related conditions in women, particularly around menopause.
How similar studies have performed: While the effects of estradiol on stress reactivity have been explored, this specific approach using neuroimaging and a controlled design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Where this trial is running
Tuebingen, BW
- University of Tuebingen; Department of Psychiatry & Psychotherapy — Tuebingen, Bw, Germany (Recruiting)
Study contacts
- Principal investigator: Birgit Derntl, Prof. — Departement of Psychiatry & Psychotherapy
- Study coordinator: Birgit Derntl, Prof.
- Email: birgit.derntl@med.uni-tuebingen.de
- Phone: 0049 07071 2985437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.