The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling

Launched by RIGSHOSPITALET, DENMARK · Jan 14, 2022

Keywords

ClinConnect Summary

The Pill Project is a clinical trial that aims to understand how starting oral contraceptives (OCs) may affect mood and brain chemistry in young women. Previous research suggests that using OCs might increase the risk of depression, and this study will investigate whether changes in a specific part of the brain linked to mood—called the serotonin 4 receptor—could be related to these feelings. Healthy women aged 18-22 who have regular menstrual cycles and have not used hormonal birth control in the past year may be eligible to participate.

Participants in the study will receive either the oral contraceptive Femicept or a placebo (a non-active pill) for three months. They will undergo brain scans and cognitive tests before starting the treatment and again after three months. Throughout the study, participants will also fill out daily questionnaires to track changes in their mood and sexual desire. This research is important because it could help scientists understand the effects of oral contraceptives on mental health and inform future treatment options for women.

Gender

FEMALE

Eligibility 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