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Microdosing LSD in Women With Premenstrual Disorders

NCT07189299 · L4Her · Friederike Holze

Closed to entry
Status
Not accepting participants
Not applicable
Phase
150
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in premenstrual symptom burden

    Measured over Daily over the 5 cycle study course (average cycle duration is 28 days)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion crtieria: * Between 18-45 years. * Are menstruating and have cycles with a duration between 21 - 35 days. * Meet DSM-V criteria for PMDD or criteria for severe PMS with daily ratings over 2 cycles to confirm luteal symptoms. 1. For PMDD, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 5 Symptoms on the DRSP including 1 mood symptom during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase score must not be \>2 on these same items. 2. For severe PMS, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 4 Symptoms on the DRSP including 1 mood symptom, during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase core must not be \>2 on these same items. * Have reported PMDD/PMS symptoms for the majority of menstrual cycles (\>9 of 12) during the year prior to screening. * Sufficient understanding of the German language * Sufficient understanding of the study procedures and risks associated with the study. * Participants must be willing to adhere to the study procedures and sign the consent form. * Willing not to drive or operate heavy machinery during the acute treatment phases of the study. * Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, and any illicit substances. * Willing to use effective contraceptive measures throughout study participation. Exclusion Criteria: * Known hypersensitivity to LSD * Current treatment for PMS/PMDD * Use of an oral hormonal contraceptive \< 6 months. * Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features. * First degree relative with a psychotic disorder. * Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6). * Borderline personality disorder. * Current post-traumatic stress disorder. * Pregnant or breastfeeding * Planned pregnancy. * Current or recent history of significant suicide ideation or suicide behavior within the past 6 months. * Current substance use disorder (\< 12 months) other than tobacco smoking. * Other illness that excludes repeated LSD administration or requires interfering medication. * Participation in another clinical trial (currently or within the last 30 days)

Where

1 study site

FacilityCityRegionCountry
Clinical Pharmacology & Toxicology, University Hospital BaselBaselCanton of Basel-CitySwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07189299 on ClinicalTrials.gov →

Last updated in the registry 2025-09-23. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance