NCT07189299

Microdosing LSD in Women With Premenstrual Disorders

Role of the Serotonin 2A Receptor in Women With Premenstrual Disorders: a Randomized, Double-blind, Placebo-controlled Study (L4Her-Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Friederike Holze · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to investigate the role of the serotonin 2A receptor in women with premenstrual disorders. This study uses a double-blind, randomized, controlled design with 3 arms: Intervention 1: 10 micg LSD for \~10 days during the late luteal phase (for 3 cycles) Intervention 2: 10 micg LSD every other day for \~10 days during the late luteal phase (for 3 cycles) Control intervention: Placebo for \~10 days during the late luteal phase (for 3 cycles) Each participant will be treated in only one arm. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase.

Detailed description

Premenstrual disorders (premenstrual syndrome (PMS) and Premenstrual Dysphoric Disorder (PMDD)) affect many women (20 - 30% for PMS and 1.2 - 6.4% for PMDD) and are associated with affective symptoms, pain, mood impairment, insomnia, loss of well-being, and productivity making it complex disorders with combined mood, physical, and cognitive symptoms. The serotonin 2A receptor has been shown to be potentially involved in the pathophysiology of premenstrual disorders, however the mechanism remains to be investigated. Anecdotal evidence suggests that low doses of psychedelics like LSD or psilocybin, taken during the luteal phase, may help alleviate symptoms. However, this approach lacks scientific validation and requires further research. We therefore seek to investigate if repeated and targeted administration of low doses of the serotonin 2A receptor agonist LSD modulates the symptom burden in premenstrual disorders. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase. Timepoints below are based on a 28-day menstrual cycle, but will be adapted based on individual menstrual cycle durations.

Conditions

• PMS
• PMDD

Interventions

Type	Name	Description
DRUG	LSD 10 μg every Day	Participants will receive 10 μg LSD every day during the luteal phase
DRUG	LSD 10 μg every other day	Participants receive 10μg LSD every second day during the luteal phase
DRUG	Placebo	Participants receive inactive placebo during the luteal phase

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-11-01
• Completion: 2030-01-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: Switzerland