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New treatment option for The Focus of the Study is to Investigate Reversible Effects of...
Official title Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission
ClinicalTrials.gov ID: NCT07511439
What this study is testing
What is Discontinuation of 2nd generation combined oral contraceptive use?
Discontinuation of 2nd generation combined oral contraceptive use is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for the focus of the study is to investigate reversible effects of combined oral contraceptive use on serotonergic neurotransmission.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy women (assigned female at birth) at 18-39 years of age
- Currently using a second-generation combined oral contraceptive containing 150 ug levonorgestrel and 30 ug ethinylestradiol for at least 3 months
You likely can't join if
- Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs (including psychoactive medication)...
- Non-fluent in Danish or pronounced visual or auditory impairments
- Current or past learning disability
- Pregnancy within the last year or previous pregnancy lasting into second or third trimester
- A wish to become pregnant within the following 12 months
- Participation in experiments with exposure to radioactivity (\> 10 mSv) within the last year or significant occupational exposure to radioactivity
See the full eligibility criteria
- Healthy women (assigned female at birth) at 18-39 years of age
- Currently using a second-generation combined oral contraceptive containing 150 ug levonorgestrel and 30 ug ethinylestradiol for at least 3 months
- Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs (including psychoactive medication) likely to influence the test results
- Non-fluent in Danish or pronounced visual or auditory impairments
- Current or past learning disability
- Pregnancy within the last year or previous pregnancy lasting into second or third trimester
- A wish to become pregnant within the following 12 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)
- A history of head injury or concussion resulting in loss of consciousness for more than 2 min
- Alcohol or drug abuse
- Drug use other than tobacco and alcohol within the last 30 days
- Cannabis \> 50 x lifetime
- Recreational drugs other than cannabis \> 10 x lifetime (for each substance)
- Nicotine addiction
- Non-compliance to COC within the last 3 months (i.e., \> 2 missed pills in a cycle)
- Contraindication for use of combined oral contraception
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.