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Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission

NCT07511439 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-02

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

Discontinuation of 2nd generation combined oral contraceptive use

Discontinuation of 2nd generation combined oral contraceptive use

DRUG

Continuation of 2nd generation combined oral contraceptive use

Continuation of 2nd generation combined oral contraceptive use

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Søren Vinther Larsen, MD, PhD · Neurobiology Research Unit, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511439 on ClinicalTrials.gov