Reversible Effects of Stopping Oral Contraceptives on Brain Serotonin Receptors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomly assign healthy women aged 18-39 who currently use a specific combined oral contraceptive to discontinue or continue use for up to one year. Brain imaging with PET will measure 5-HT4 receptor binding at baseline and after follow-up to see if stopping the pill restores receptor levels toward those seen in non-users. The study also explores how changes relate to mood, memory, and sexual desire, with the goal of understanding whether any COC-related brain changes are reversible. Up to 60 participants will be enrolled at Copenhagen University Hospital, Rigshospitalet, with careful screening for MRI safety and other eligibility factors.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurobiology Research Unit (NRU)
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Søren Vinther Larsen, MD, PhD — Neurobiology Research Unit, Rigshospitalet
• Study coordinator: Søren Vinther Larsen, MD, PhD
• Email: soren.vinther@nru.dk
• Phone: +45 35456708

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biomarker test for brown rice components in healthy adults

  This study will test whether specific biomarkers in blood and urine reflect acute brown rice intake in healthy men and women.

  Recruiting North Carolina Agriculture & Technical State University · Kannapolis, North Carolina · NCT07898137

• Dermial skin-brightening supplement study in healthy adult women

  A daily 60 mg Dermial® supplement or placebo is being tested for 12 weeks to see if it improves skin brightness and related signs in healthy women aged 35–65 with mild to moderate facial ageing.

  Recruiting Bioiberica · Madrid, Madrid · NCT07790237

• Pharmacokinetics of Whole-Grain Corn: What Happens After Eating

  This study tests how healthy adults absorb and excrete components from whole-grain corn by giving two types of corn on different days and measuring biomarkers in blood, urine, and feces.

  Recruiting North Carolina Agriculture & Technical State University · Kannapolis, North Carolina · NCT07767162

• Inhaling hydrogen before exercise to see how the body uses energy in healthy women

  This study tests whether inhaling molecular hydrogen for a week changes metabolic responses during graded exercise in healthy young women.

  Recruiting Palacky University · Olomouc · NCT07644000

• Biphasic IVM for POSEIDON Group 1 in young women with poor response

  This trial tests whether a two-step in vitro maturation process can help young women with normal ovarian reserve who retrieve too few eggs after standard stimulation.

  Recruiting Mỹ Đức Hospital · Ho Chi Minh City, Hồ Chí Minh · NCT07632300

• Olive oil extract for improving knee comfort and function

  This will test whether taking an olive oil extract every day for six weeks helps reduce knee pain and improve knee function in adults 40–75 who have ongoing knee discomfort.

  Recruiting Applied Food Sciences Inc. · San Francisco, California · NCT07514013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.