Search / Trial NCT06223126

Stress Reactivity and Hormonal Contraception

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jan 15, 2024

Trial Information

Current as of October 03, 2024

Enrolling by invitation

Keywords

Stress Reactivity Mood Homeostasis F Mri Oral Contraceptive Sex Hormones Cortisol

Description

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Tübingen, Baden Württemberg, Germany

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0