PMSL4HerNCT07189299
Microdosing LSD in Women With Premenstrual Disorders
A study testing LSD 10 μg every Day and LSD 10 μg every other day in people with PMS and PMDD, run by Friederike Holze at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- LSD 10 μg every Day and LSD 10 μg every other day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2025to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, Canton of Basel-City, 4056
Friederike Holze, Dr., +41613287735, friederike.holze@usb.ch
About this study
Official title: Role of the Serotonin 2A Receptor in Women With Premenstrual Disorders: a Randomized, Double-blind, Placebo-controlled Study (L4Her-Study)
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.
Read the 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.
- Being tested
- LSD 10 μg every Day, LSD 10 μg every other day, Placebo
- Keywords
- Hallucinogens, Serotonin Agents, LSD, Premenstrual disorders, Premenstrual syndrome, Psychotropic drugs, Microdose, Serotonin system, Psychedelics
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSD 10 μg every DayDrug
Participants will receive 10 μg LSD every day during the luteal phase
LSD 10 μg every other dayDrug
Participants receive 10μg LSD every second day during the luteal phase
PlaceboDrug
Participants receive inactive placebo during the luteal phase
| Study group | Role | What they receive |
|---|---|---|
| 10 μg LSD every day during the acute symptom phase | Experimental | Participants receive 10 μg LSD daily, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles Receives: Drug: LSD 10 μg every Day |
| 10 μg LSD every second day during acute symptom phase | Experimental | 10 μg LSD every second day during acute symptom phase starting at symptom onset (or 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles Receives: Drug: LSD 10 μg every other day |
| Placebo Control | Placebo comparator | The subjects in the control arm will receive oral placebo over 3 cycles during the luteal phase, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in premenstrual symptom burden
Premenstrual symptom burden measured with the Daily Record of Severity of Problems (DRSP) total score as the mean of the 5 highest symptomatic days of the 7 days before menstruation onset as mean change from baseline (the two monitored cycles before treatment start) of symptoms over all three treatment periods compared with the other study arms.
Measured: Daily over the 5 cycle study course (average cycle duration is 28 days)
Secondary outcomes (20)
Montgomery-Asberg-Depression-Rating Scale (MARDS)
The Montgomery-Asberg-Depression Rating Scale (MADRS) is a ten-item questionnaire widely used to measure severity of depressive symptoms.
Measured: Ratings will be performed on day 3 of each menstural cycle, over the whole study period of 5 menstrual cycles, to retrospectively rate depressive symptoms during the premenstrual phase (based on an average cycle duration of 28 days)
Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated scale developed to measure the severity of anxiety symptoms.
Measured: Ratings will be performed on day 3 of each menstural cycle , over the whole study period of 5 menstrual cycles to retrospectively rate anxiety symptoms during the premenstrual phase ((based on an average cycle duration of 28 days).
State-trait anxiety inventory (STAI)
The State-trait anxiety inventory (STAI) is a widely used self-report instrument for assessing anxiety in adults. It includes separate measures of state and trait anxiety.
Measured: The STAI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.
Beck Depression Inventory (BDI)
The BDI consists of 21 questions developed to measure depression severity. In contrast to the MADRS, the BDI is a self-rating instrument.
Measured: The BDI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.
Quality of Life (WHOQOL-bref)
The WHOQOL-bref (World Health Organization Quality of life scale) is one of the most commonly used self-rating instruments for the assessment of the quality of life. The scale includes 26 items and four domain scores can be derived (physical, psychological, social relationships, and environmental).
Measured: The WHOQOL-bref will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of me, additionally it will be assessed at screening and once during the luteal phase
Menstrual pain
Menstrual pain will be assessed via 3 main questions. 1.) Did you experience any menstruation-related pain today? (VAS 0-100) 2.) Did you do anything for pain relief? (YES / NO). If "YES" 3a.) Did you take any medication? If yes, what, how much and how often? 3b.) Did you conduct any non-drug treatment? If yes, what, how much and how often? 3c.) Other? (free answer).
Measured: Menstrual pain will be assessed on menstruation days over 5 menstrual cycles (average cycle duration is 28 days).
Quality of Sleep
Rating consists of 5 questions. 1. How did you sleep? (bidirectional VAS from -50 very bad to 50 very good). 2. How fast did you fall asleep (bidirectional VAS from -50 very fast to 50 not at all) 3. Did you wake-up during the night? (YES/NO, if YES, how many times?) 4. Do you feel refreshed? (bidirectional VAS from -50 not at all to 50 very much) 5. Did you have a hard time waking-up this morning? (bidirectional VAS from -50 not at all to 50 very much).
Measured: Participants are asked to rate their sleep quality daily over 5 menstrual cycles (average cycle duration is 28 days).
Daily mood (AMRS)
The Adjective Mood Rating Scale (AMRS or EWL60S) is a 60-item Likert scale that allows repeated assessment of mood.
Measured: The AMRS will be administered daily over 5 menstrual cycles (average cycle duration is 28 days).
Female Sexual Function Index (FSFI)
The FSFI is a comprehensive, validated tool designed to assess key dimensions of sexual function in women.
Measured: The outcome will be on day 3 of each menstural cycle to retrospectively rate sexual function during the premenstrual phase over 5 menstrual cycles (average cycle duration is 28 days).
Concomitant Medication
Intake of pain medication during acute treatment phases and menstruation
Measured: Complete concomitant medication including on-demand medication during bleeding days (dysmenorrhea) will be assessed at screening and rescreening. The exact intake will be recorded daily over 5 menstrual cycles (average cycle duration is 28 days).
Subjective effects questionnaire (Visual Analog Scales, VAS)
VAS will be repeatedly used during the first drug sessions to assess subjective effects. The following VAS will be used: "any drug effect", "good drug effect", "bad drug effect", "liking", "high", "anxiety". The maximal ratings (Emax, 0-100) and area under the effect curve (AUEC) values will be defined for each VAS item and Emax and AUEC values will be compared between treatments using ANOVAs.
Measured: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation (average cycle duration is 28 days). Scales will be administered at 0, 0.5, 1, 2, 3, 4, 5, and 6 hours after substance administration.
5-Dimensions of Altered States of Consciousness (5D-ASC)
The 5 Dimensions of Altered States of Consciousness (5D-ASC) Scale is a questionnaire containing visual analog scales for 94 items to restrospectively assess peak alterations in state of consciousness.
Measured: Only once 6 hours after drug administration on the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days)
Mystical Effects Questionnaire (MEQ)
Measured: Only once 6 hours after drug administration on the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days)
List of complaints (LC)
The list of complaints (LC) consists consists of a 40-items list to assess physiological complaints throughout the study.
Measured: Twice during the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days) baseline (before drug administration) and 6 hours after drug administration.
Changes in cognition
Cognition will be assessed using CANTAB tasks.
Measured: Once during the luteal phase of an unmedicated cycle (cycle day 26 based on a 28-day cycle), once during the luteal phase of a medicated cycle (cycle day 26 based on a 28-day cycle), and once during the follicular phase of a medicated cycle.
Blood pressure
Systolic and diastolic blood pressure will be repeatedly measured during the first drug administration.
Measured: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after substance administration (average cycle duration is 28 days).
Heart rate
Measured: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after substance administration (average cycle duration is 28 days).
Expectancy as mediator for treatment effects
To measure expectancy, we will use a modified 2-item version of the Credibility / Expectancy Questionnaire (CEQ).
Measured: Baseline
Personality traits as mediator for treatment effects (NEO-FFI)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The NEO Five Factor Inventory (NEO-FFI) is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness.
Measured: Baseline
Personality traits as mediator for treatment effects (FPI-R)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Freiburger Personality Inventory (FPI-R) version comprises 138 items and covers 12 dimensions of personality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, double-blind, placebo-controlled, parallel design with 3 intervention arms. Participants will be allocated in a 1:1:1 ratio to one arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friederike Holze
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Friederike Holze, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189299
- Sponsor's protocol ID
- BASEC 2025-00745
- Acronym
- L4Her
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Serotonin 2A Receptor in Women With Premenstrual Disorders: a Randomized, Double-blind, Placebo-controlled Study (L4Her-Study)
- ClinicalTrials.gov ID
- NCT07189299
- Acronym / sponsor ID
- L4Her / BASEC 2025-00745
- Keywords
- Hallucinogens, Serotonin Agents, LSD, Premenstrual disorders, Premenstrual syndrome, Psychotropic drugs, Microdose, Serotonin system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Friederike HolzeUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a randomized, double-blind, placebo-controlled, parallel design with 3 intervention arms. Participants will be allocated in a 1:1:1 ratio to one arm.
| Arm | Type | Receives |
|---|---|---|
| 10 μg LSD every day during the acute symptom phase | Experimental | Drug: LSD 10 μg every DayParticipants receive 10 μg LSD daily, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles |
| 10 μg LSD every second day during acute symptom phase | Experimental | Drug: LSD 10 μg every other day10 μg LSD every second day during acute symptom phase starting at symptom onset (or 7 days after ovulation) until day 3 of the following cycle for 3 menstrual cycles |
| Placebo Control | Placebo comparator | Drug: PlaceboThe subjects in the control arm will receive oral placebo over 3 cycles during the luteal phase, starting at symptom onset (or latest 7 days after ovulation) until day 3 of the following cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSD 10 μg every DayParticipants will receive 10 μg LSD every day during the luteal phase | Drug | 10 μg LSD every day during the acute symptom phase |
| LSD 10 μg every other dayParticipants receive 10μg LSD every second day during the luteal phase | Drug | 10 μg LSD every second day during acute symptom phase |
| PlaceboParticipants receive inactive placebo during the luteal phase | Drug | Placebo Control |
Primary outcome
Change in premenstrual symptom burden
Time frame: Daily over the 5 cycle study course (average cycle duration is 28 days)
Premenstrual symptom burden measured with the Daily Record of Severity of Problems (DRSP) total score as the mean of the 5 highest symptomatic days of the 7 days before menstruation onset as mean change from baseline (the two monitored cycles before treatment start) of symptoms over all three treatment periods compared with the other study arms.
20 secondary outcomes
Montgomery-Asberg-Depression-Rating Scale (MARDS)
Time frame: Ratings will be performed on day 3 of each menstural cycle, over the whole study period of 5 menstrual cycles, to retrospectively rate depressive symptoms during the premenstrual phase (based on an average cycle duration of 28 days)
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Ratings will be performed on day 3 of each menstural cycle , over the whole study period of 5 menstrual cycles to retrospectively rate anxiety symptoms during the premenstrual phase ((based on an average cycle duration of 28 days).
State-trait anxiety inventory (STAI)
Time frame: The STAI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.
Beck Depression Inventory (BDI)
Time frame: The BDI will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of mensturation) over the whole study period of 5 menstrual cycles.
Quality of Life (WHOQOL-bref)
Time frame: The WHOQOL-bref will be repeatedly assessed 3 times per cycle (twice during the late luteal phase (cycle day 20 and 26 based on a 28-day cycle) and on day 3 after start of me, additionally it will be assessed at screening and once during the luteal phase
Menstrual pain
Time frame: Menstrual pain will be assessed on menstruation days over 5 menstrual cycles (average cycle duration is 28 days).
Quality of Sleep
Time frame: Participants are asked to rate their sleep quality daily over 5 menstrual cycles (average cycle duration is 28 days).
Daily mood (AMRS)
Time frame: The AMRS will be administered daily over 5 menstrual cycles (average cycle duration is 28 days).
Female Sexual Function Index (FSFI)
Time frame: The outcome will be on day 3 of each menstural cycle to retrospectively rate sexual function during the premenstrual phase over 5 menstrual cycles (average cycle duration is 28 days).
Concomitant Medication
Time frame: Complete concomitant medication including on-demand medication during bleeding days (dysmenorrhea) will be assessed at screening and rescreening. The exact intake will be recorded daily over 5 menstrual cycles (average cycle duration is 28 days).
Subjective effects questionnaire (Visual Analog Scales, VAS)
Time frame: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation (average cycle duration is 28 days). Scales will be administered at 0, 0.5, 1, 2, 3, 4, 5, and 6 hours after substance administration.
5-Dimensions of Altered States of Consciousness (5D-ASC)
Time frame: Only once 6 hours after drug administration on the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days)
Mystical Effects Questionnaire (MEQ)
Time frame: Only once 6 hours after drug administration on the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days)
List of complaints (LC)
Time frame: Twice during the first in-house drug application (cycle 3, latest 7 days after ovulation, average cycle duration is 28 days) baseline (before drug administration) and 6 hours after drug administration.
Changes in cognition
Time frame: Once during the luteal phase of an unmedicated cycle (cycle day 26 based on a 28-day cycle), once during the luteal phase of a medicated cycle (cycle day 26 based on a 28-day cycle), and once during the follicular phase of a medicated cycle.
Blood pressure
Time frame: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after substance administration (average cycle duration is 28 days).
Heart rate
Time frame: Will be assessed during the first drug administration in cycle 3, latest 7 days after ovulation -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after substance administration (average cycle duration is 28 days).
Expectancy as mediator for treatment effects
Time frame: Baseline
Personality traits as mediator for treatment effects (NEO-FFI)
Time frame: Baseline
Personality traits as mediator for treatment effects (FPI-R)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for PMS
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Not yet recruitingObservational study
A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSD 10 μg every Day and LSD 10 μg every other day in people with PMS and PMDD, run by Friederike Holze at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Friederike Holze, Dr. (+41613287735, friederike.holze@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in premenstrual symptom burden (time frame: Daily over the 5 cycle study course (average cycle duration is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.