Stress Reactivity and Hormonal Contraception
Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jan 15, 2024
Trial Information
Current as of March 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The study will use a longitudinal design with two time points to compare three groups, the women who want to start taking the pill, the women who want to stop taking it, and those who are long-term users of the pill. They will be exposed to a psychosocial stress induction task (Montreal Imaging Stress Task; MIST) in functional magnetic resonance imaging (fMRI) to get mechanistic insights. Measurements will be done before and during OC use (group 1; OC-Starters) and during and after the termination of OC use (group 2; OC-Stoppers). Therefore, at the first time point (T1) of the measurements,...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Women, who want to start using oral contraception (no hormonal contraception use for at least 4 months; regular menstrual cycle (between 25 and 35 days) prior to participation)
- • Women, who want to stop using oral contraception (OC pill use for at least 6 months; regular intake of OC pill)
- • Long-term oral contraception user (OC pill use for at least 6 months; regular intake of OC pill)
- • German language fluency
- • Normal or corrected vision
- • Body-mass index (BMI): 18-35 kg/m2
- Exclusion Criteria:
- • Neurological or psychiatric disease
- • Medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, or congestive heart failure)
- • 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 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
Trial Officials
Nils B. Kroemer, Professor
Principal Investigator
Department of Psychiatry & Psychotherapy, University of Tübingen
About University Hospital Tuebingen
University Hospital Tübingen is a leading academic medical institution in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its multidisciplinary expertise and cutting-edge facilities to develop new therapeutic strategies and improve patient outcomes. With a strong focus on translational medicine, University Hospital Tübingen collaborates with various stakeholders, including pharmaceutical companies and research organizations, to facilitate the efficient and ethical conduct of trials across a wide range of medical disciplines. Their dedication to patient-centered research and rigorous scientific standards positions them at the forefront of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tübingen, Baden Württemberg, Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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