RecruitingPhase 4NCT07511439

Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission


Sponsor

Rigshospitalet, Denmark

Enrollment

60 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Continuation of 2nd generation combined oral contraceptive use and a drug called Discontinuation of 2nd generation combined oral contraceptive use for people with healthy adult females and the focus of the study is to investigate reversible effects of combined oral contraceptive use on serotonergic neurotransmission. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDiscontinuation of 2nd generation combined oral contraceptive use

Discontinuation of 2nd generation combined oral contraceptive use

DRUGContinuation of 2nd generation combined oral contraceptive use

Continuation of 2nd generation combined oral contraceptive use


Locations(1)

Neurobiology Research Unit (NRU)

Copenhagen, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07511439


Related Trials