[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607495":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":62,"collaborators":31,"id":66,"slug":31,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":31,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":96,"whyStopped":31,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Drug: LSD 10 μg every Day",{"label":15,"type":10,"description":16,"interventionNames":17},"10 μg LSD every second day during acute symptom phase","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",[18],"Drug: LSD 10 μg every other day",{"label":20,"type":21,"description":22,"interventionNames":23},"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.",[24],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","LSD 10 μg every Day","Participants will receive 10 μg LSD every day during the luteal phase",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"LSD 10 μg every other day","Participants receive 10μg LSD every second day during the luteal phase",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo","Participants receive inactive placebo during the luteal phase",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Friederike Holze, Dr.","CONTACT","+41613287735","friederike.holze@usb.ch",[47],{"facility":48,"status":31,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Clinical Pharmacology & Toxicology, University Hospital Basel","Basel","Canton of Basel-City","4056","Switzerland","CH",{"type":55,"coordinates":56},"Point",[57,58],7.57327,47.55839,{"lat":58,"lon":57},[61],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Friederike Holze","Head of Clinical Research","100607495",false,"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)","L4Her","Inclusion crtieria:\n\n* Between 18-45 years.\n* Are menstruating and have cycles with a duration between 21 - 35 days.\n* Meet DSM-V criteria for PMDD or criteria for severe PMS with daily ratings over 2 cycles to confirm luteal symptoms.\n\n  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.\n  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.\n* Have reported PMDD\u002FPMS symptoms for the majority of menstrual cycles (\\>9 of 12) during the year prior to screening.\n* Sufficient understanding of the German language\n* Sufficient understanding of the study procedures and risks associated with the study.\n* Participants must be willing to adhere to the study procedures and sign the consent form.\n* Willing not to drive or operate heavy machinery during the acute treatment phases of the study.\n* Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, and any illicit substances.\n* Willing to use effective contraceptive measures throughout study participation.\n\nExclusion Criteria:\n\n* Known hypersensitivity to LSD\n* Current treatment for PMS\u002FPMDD\n* Use of an oral hormonal contraceptive \\\u003C 6 months.\n* Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.\n* First degree relative with a psychotic disorder.\n* Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6).\n* Borderline personality disorder.\n* Current post-traumatic stress disorder.\n* Pregnant or breastfeeding\n* Planned pregnancy.\n* Current or recent history of significant suicide ideation or suicide behavior within the past 6 months.\n* Current substance use disorder (\\\u003C 12 months) other than tobacco smoking.\n* Other illness that excludes repeated LSD administration or requires interfering medication.\n* Participation in another clinical trial (currently or within the last 30 days)","FEMALE","18 Years","45 Years",{"count":77,"type":78},150,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85],"PMS","PMDD",[87,88,89,90,91,92,93,94,95],"Hallucinogens","Serotonin Agents","LSD","Premenstrual disorders","Premenstrual syndrome","Psychotropic drugs","Microdose","Serotonin system","Psychedelics","NOT_YET_RECRUITING","2025-09-16",{"date":99,"type":100},"2025-09-23","ACTUAL",{"date":102,"type":78},"2025-10-01",{"date":104,"type":78},"2030-01-01",{"name":64,"class":6},1]