Status:
RECRUITING
Estradiol and Stress Reactivity in Women
Lead Sponsor:
International Research Training Group 2804
Collaborating Sponsors:
University Hospital Tuebingen
German Research Foundation
Conditions:
Stress vs. Control
Estradiol vs. Placebo
Eligibility:
FEMALE
18-60 years
Brief 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 dise...
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 experimental...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06204016
Start Date
March 7 2024
End Date
December 1 2025
Last Update
March 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Tuebingen; Department of Psychiatry & Psychotherapy
Tübingen, Baden-Wurttemberg, Germany, 72076