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Stress Reactivity and Hormonal Contraception

NCT06223126 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-03-01

No results posted yet for this study

Summary

For almost 60 years, millions of women globally have relied on oral contraceptive (OC) pills for pregnancy prevention and addressing menstrual irregularities. However, 4-10% of users experience mood-related side effects such as depression and anxiety, often leading to discontinuation of OC use. Previous studies also indicate that OC usage may lead to chronic alterations in brain structure and the regulation of the hypothalamic-pituitary-adrenal axis, a system involved in regulating stress responses. In the proposed study the investigators aim to investigate in more detail how women who start taking oral contraception (OC) and women who stop taking OC differ in their stress reactivity and their mood from long-term OC users. Furthermore, assessing hormones will help to shed light on the connection between OC, stress reaction, sex hormones and the brain. To achieve this, individual biomarkers will be evaluated, including changes in brain anatomy, functional responses and connectivity during acute psychosocial stress and early changes in mood and well-being through ambulatory assessment.

Conditions

  • Hormonal Contraception

Interventions

OTHER

Combined oral contraception

Women, who want to start taking birth control pills will get a prescription for oral contraception at the discretion of their own attending physician

OTHER

Discontinuation of a combined oral contraception

Cessation of the use of combined oral contraceptives

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • German Research Foundation

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Nils B. Kroemer, Professor · Department of Psychiatry & Psychotherapy, University of Tübingen

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223126 on ClinicalTrials.gov