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Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission

RecruitingPhase 4Ages 18 Years - 39 YearsFemaleCopenhagen University Hospital, Rigshospitalet
NCT07511439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to learn about potential reversible effects of combined oral contraceptive (COC) use on the serotonergic brain system. The main question it aims to answer is: \- If COC discontinuation results in an increase in serotonin 4 receptor binding in caudate, putamen, and hippocampus measured with Positron Emission Tomography from baseline to follow-up ≥ week 8 after discontinuation. The secondary question it aims to answer is: \- Over what timeframe the serotonin 4 receptor binding is restored after COC discontinuation to the level previously seen in a group of premenopausal women who had not used hormonal contraception before. Researchers will compare discontinuation with continuation of a 2nd generation COC containing 150 ug levonorgestrel and 30 microgram to see if COC discontinuation results in an increased serotonin 4 receptor level in the brain. \- Particip

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Healthy women (assigned female at birth) at 18-39 years of age 2. Currently using a second-generation combined oral contraceptive containing 150 ug levonorgestrel and 30 ug ethinylestradiol for at least 3 months Exclusion Criteria: 1. Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs (including psychoactive medication) likely to influence the test results 2. Non-fluent in Danish or pronounced visual or auditory impairments 3. Current or past learning disability 4. Pregnancy within the last year or previous pregnancy lasting into second or third trimester 5. A wish to become pregnant within the following 12 months 6. Participation in experiments with exposure to radioactivity (\> 10 mSv) within the last year or significant occupational exposure to radioactivity 7. Contraindications for MRI (pacemaker, metal implants, claustrophobia) 8. A history of head injury or concussion resulting in loss of consciousness for more than 2 min 9. Alcohol or drug abuse 10. Drug use other than tobacco and alcohol within the last 30 days 11. Cannabis \> 50 x lifetime 12. Recreational drugs other than cannabis \> 10 x lifetime (for each substance) 13. Nicotine addiction 14. Non-compliance to COC within the last 3 months (i.e., \> 2 missed pills in a cycle) 15. Contraindication for use of combined oral contraception
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What it tests

  • Discontinuation of 2nd generation combined oral contraceptive use
  • Continuation of 2nd generation combined oral contraceptive use
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Where

1 site
Neurobiology Research Unit (NRU)
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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