Search / Trial NCT06223126

Stress Reactivity and Hormonal Contraception

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jan 15, 2024

Trial Information

Current as of December 30, 2024

Enrolling by invitation

Keywords

Stress Reactivity Mood Homeostasis F Mri Oral Contraceptive Sex Hormones Cortisol

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.

Locations

Tübingen, Baden Württemberg, Germany

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0