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Clinical Trials in Denmark / NCT07511439
Recruiting Phase 4

Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission

NCT07511439 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Phase 4
Started
2026-04-23
Last updated
2026-07-02

Condition(s) studied

The Focus of the Study is to Investigate Reversible Effects of Combined Oral Contraceptive Use on Serotonergic NeurotransmissionHealthy Adult Females

Investigational drug(s) / intervention(s)

Discontinuation of 2nd generation combined oral contraceptive useContinuation of 2nd generation combined oral contraceptive use

Discontinuation of 2nd generation combined oral contraceptive use: Discontinuation of 2nd generation combined oral contraceptive use

Continuation of 2nd generation combined oral contraceptive use: Continuation of 2nd generation combined oral contraceptive use

Study summary

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.

\-

Participants will:

* Be randomized to discontinue or continue their COC use for 1-52 weeks.
* Undergo an investigational program including brain scans, biological sampling, and neuropsychological testing at baseline and at follow-up.

The study uses a group sequential design with two sequential analyses planned, including an interim analysis after 60% of the brain scans have been acquired, which will be used to decide the timing of the last 40% of the scans - this is performed to best determine when the recovery of the serotonin 4 receptor level occurs.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
39 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in global serotonin 4 receptor (5-HT4R) brain binding across caudate, putamen, and hippocampus — 1-52 weeks
    Serotonin 4 receptor (5-HT4R) brain binding is measured with positron emission tomography. Change in global 5-HT4R brain binding is estimated using a latent variable model with a latent variable pooling the change in log-transformed binding potentials from baseline to follow-up across caudate, putamen, and hippocampus after adjustment for change in injected tracer mass per kg body weight.

Trial sites (1)

FacilityCityRegionStatus
Neurobiology Research Unit (NRU) Copenhagen Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511439 on ClinicalTrials.gov ↗ ← All trials in Denmark