[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646706":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":14,"centralContacts":18,"locations":24,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Lancaster University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"control group",null,"oestrogen and progesterone levels and ratios 5-7 days post ovulation",{"label":13,"type":10,"description":11,"interventionNames":10},"PMDD group",[15],{"name":16,"affiliation":5,"role":17},"Chris Gaffney, BSc (Hons.) MSc PhD SFHEA","STUDY_DIRECTOR",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Milli Raizada, MBCHB Hons","CONTACT","+44 (0)1524 65201","m.raizada2@lancaster.ac.uk",[25],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Lancaster","Lancashire","LA1 4YW","United Kingdom","UK",{"type":33,"coordinates":34},"Point",[35,36],-2.79988,54.04649,{"lat":36,"lon":35},[39,41,43,46],{"name":40,"role":21,"phone":22,"phoneExt":10,"email":23},"Milli Raizazda, MBCHB Hons",{"name":16,"role":21,"phone":22,"phoneExt":10,"email":42},"c.gaffney@lancaster.ac.uk",{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},"milli raizada, MBCHB Hons","PRINCIPAL_INVESTIGATOR",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"chris gaffney, BSc (Hons.) MSc PhD SFHEA","SUB_INVESTIGATOR",{"type":45,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Milli Raizada","Senior Clinical Lecturer","100646706","to-establish-whether-individuals-with-premenstrual-dysphoric-disorder-pmdd-demonstrate-a-different-luteal-phase-sex-hormone-profile-and-ratio-compared-with-asymptomatic-controls-100646706",false,"NCT07686718","To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.","Inclusion criteria\n\n* Aged 18-45 years old (adults but less than the typical perimenopausal age so there is not added bias\u002Fvariable)\n* Regular menstrual cycles (21-35 days for the last 3 months)\n* Willing and able to complete a questionnaire (no new clinical diagnosis given)\n* Use home urine LH test strips to detect ovulation\n* Attend a single in person on site in Lancaster mid luteal blood test sample appointment (approx 7 days post LH surge)\n* Provide written informed consent\n* Have sufficient English language skills to understand the patient information\n* Be either in Group 1 or group 2 Group 1 (PMDD group ie case group) - self reported prior diagnosis of PMDD made by a healthcare professional (GP, psychiatrist, gynaecologist) Group 2 (Control group ie comparison group) - no prior diagnosis of PMDD made by a healthcare professional and no history of clinically significant premenstrual mood symptoms on screening\n\nExclusion criteria\n\n* Current use or use in the last 3 months of hormonal contraception such as the combined oral contraceptive pill, the progestogen only pill, the implant, the injection, hormonal coil (Mirena, Kyleena) or patch\u002Fring.\n* Current use or use in the last 3 months of any hormone replacement therapy (e.g. combined oestrogen and progesterone, oestrogen and Mirena coil combination, oestrogen alone if had a hysterectomy, or progesterone alone) or GnRH analogues use\n* On a selective serotonin reuptake inhibitor (SSRI) with a recent initiation or dose change within the last 3 months\n* Pregnant, breastfeeding or within 3 months post partum\n* Irregular menstrual cycles (outside the 21-35 day window)\n* Surgical menopause\n* Premature ovarian insufficiency\n* Other endocrine disorders e.g. uncontrolled thyroid disease, high prolactin, cushing's syndrome, polycystic ovarian syndrome)\n* Regular systemic steroid use or use of other medications known to affect sex hormone within the last 3 months\n* Severe mental health issues that impair consent or participation\n* Needle phobic so that venepuncture is intolerable\n* The use of the emergency contraceptive pill either 3 months prior to the study or during the study.",true,"FEMALE","18 Years","45 Years",{"count":63,"type":64},50,"ESTIMATED","6 Months","OBSERVATIONAL","The aim of this project is to compare the ovarian hormone levels 7 days after ovulation and progesterone:oestradiol ratios between PMDD individuals and a control cohort (case control study).",[69],"Premenstrual Dysphoric Disorder ( PMDD)",[71,72,73,74,75],"PMDD","premenstrual dysphoric disorder","oestrogen","progesterone","ratios","2026-06-29",{"date":78,"type":79},"2026-07-07","ACTUAL",{"date":81,"type":79},"2026-05-05",{"date":83,"type":64},"2027-08-01",{"name":5,"class":6},1]