The REVERSE trial examines what happens in the brain when women stop taking combined oral contraceptives (COCs). COC use suppresses natural sex hormones and replaces them with synthetic hormones. For some women the use of COC can also affect mood (including an association with increased risk of developing a depressive episode), sexual desire and cognition. In a recent randomized controlled trial, we showed that three months of COC use lowers the brain levels of the serotonin 4 receptor (5‑HT4R) by approximately 10%. The 5-HT4R is a marker implicated in mood and memory and is also reduced in patients with depression.
We aim to include 50 healthy COC users aged 18–39, where we test whether COC discontinuation restores 5‑HT4R binding (measured with PET) and map the time course of recovery. Moreover, we assess effects of COC discontinuation on mood, sexual function, cognition and metabolic and inflammatory markers. The trial is randomized, placebo‑controlled and will inform how COC use relates to brain serotonin signalling and women’s mental health.
If you would like to participate in the REVERSE trial, please go to TrialTree for more information (in Danish): https://trialtree.com/project/reverse-reversible-effekter-af-p-pilleoph%C3%B8r-p%C3%A5-hjernens-serotoninsystem
The project is funded by Lundbeckfonden, Mental Health services in the Capital Region, and Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ Legat.
Involved persons: Søren Vinther Larsen, Annika Fuglsang-Damgaard, Victoria Garre, and Vibe G. Frøkjær.