Investigating the effects of oral contraceptives on brain signaling and mood in young women
Hormonal Sensitivity and Brain Function: Do Oral Contraceptives Distort Serotonergic Brain Signaling?
This study is testing how starting oral contraceptives affects mood and brain function in healthy young women aged 18-22 to see if it can help identify those at risk for depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 22 Years |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05212389 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between oral contraceptive use and changes in serotonergic brain signaling, particularly focusing on the serotonin 4 receptor in healthy women aged 18-22. It will employ a single-blind, randomized, placebo-controlled design over a 3-month period to assess how starting oral contraceptives may influence mood, cognition, and sexual desire. Participants will undergo imaging techniques such as Positron Emission Tomography and Magnetic Resonance Imaging to evaluate brain function and structure. The goal is to identify potential biomarkers that could predict which women may be at risk for developing depressive episodes when using hormonal contraceptives.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18-22 who have not used hormonal contraception in the past year and have regular menstrual cycles.
Not a fit: Patients with current or previous neurological or psychiatric diseases, or those who have used hormonal contraception recently, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify women at risk for depression when starting oral contraceptives, leading to better-informed contraceptive choices.
How similar studies have performed: While there have been studies linking oral contraceptives to mood changes, this specific approach focusing on serotonergic signaling and imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women at 18-22 years of age * No use of hormonal contraception within the last year * Having a regular menstrual cycle of approximately 28 days, i.e., approximately 28 days between first day of menstrual bleedings. Exclusion Criteria: * Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs likely to influence the test results * Non-fluent in Danish or pronounced visual or auditory impairments * Current or past learning disability * Current or previous pregnancy * A wish to become pregnant within the following 6 months * Participation in experiments with exposure to radioactivity (\> 10 mSv) within the last year or significant occupational exposure to radioactivity * Contraindications for MRI (pacemaker, metal implants, claustrophobia) * Allergy to the ingredients in the administered drug * A diagnosis of hypo- or hypertension * A history of head injury or concussion resulting in loss of consciousness for more than 2 min * Alcohol abuse * Drug use other than tobacco and alcohol within the last 30 days * Cannabis \> 50 x lifetime * Recreational drugs \> 10 x lifetime (for each substance) * Nicotine addiction * Current psychoactive medication * Any risk factors for thromboembolic events * Other contraindications for use of Femicept
Where this trial is running
Copenhagen
- Neurobiology Research Unit — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Vibe Frokjaer, MD, PhD — Neurobiology Research Unit, Copenhagen University hospital, Rigshospitalet, Denmark
- Study coordinator: Vibe Frokjaer, MD, PhD
- Email: vibe@nru.dk
- Phone: +453545 6714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.