[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100215456":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":44,"centralContacts":48,"locations":57,"responsibleParty":78,"collaborators":34,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":34,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":60,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Kisspeptin 0.1","ACTIVE_COMPARATOR","Participants will receive kisspeptin hormone at a dose rate of 0.1nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.",[13],"Other: Kisspeptin 0.1",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline","PLACEBO_COMPARATOR","Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.",[19],"Other: Saline",{"label":21,"type":10,"description":22,"interventionNames":23},"Kisspeptin 0.3","Participants will receive kisspeptin hormone at a dose rate of 0.3nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.",[24],"Other: Kisspeptin 0.3",{"label":26,"type":10,"description":27,"interventionNames":28},"Kisspeptin 1.0","Participants will receive kisspeptin hormone at a dose rate of 1.0nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.",[29],"Other: Kisspeptin 1.0",[31,35,38,41],{"type":6,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"Participants will receive kisspeptin hormone at a dose rate of 0.1nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.\n\nLH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.",[9],null,{"type":6,"name":15,"description":36,"armGroupLabels":37,"otherNames":34},"Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.\n\nLH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.",[15],{"type":6,"name":21,"description":39,"armGroupLabels":40,"otherNames":34},"Participants will receive kisspeptin hormone at a dose rate of 0.3 nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.\n\nLH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.",[21],{"type":6,"name":26,"description":42,"armGroupLabels":43,"otherNames":34},"Participants will receive kisspeptin hormone at a dose rate of 1.0 nmol\u002Fkg\u002Fhour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.\n\nLH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.",[26],[45],{"name":46,"affiliation":5,"role":47},"Waljit Dhillo, PhD, FRCP","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":34,"email":53},"ALi Abbara, PhD MRCP","CONTACT","020 8383 3242","ali.abbara@imperial.ac.uk",{"name":55,"role":51,"phone":52,"phoneExt":34,"email":56},"Debbie A Papadopoulou, BSc MRes","d.papadopoulou@imperial.ac.uk",[58],{"facility":59,"status":60,"city":61,"state":34,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Imperial College NHS Healthcare Trust","RECRUITING","London","W12 0NN","United Kingdom","UK",{"type":66,"coordinates":67},"Point",[68,69],-0.12574,51.50853,{"lat":69,"lon":68},[72,74,77],{"name":46,"role":51,"phone":52,"phoneExt":34,"email":73},"w.dhillo@imperial.ac.uk",{"name":75,"role":51,"phone":52,"phoneExt":34,"email":76},"Channa Jayasena, MBBS, PhD","c.jayasena@imperial.ac.uk",{"name":46,"role":47,"phone":34,"phoneExt":34,"email":34},{"type":79,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100215456","reproductive-hormones-during-sustained-administration-of-kisspeptin-100215456",false,"NCT02081924","Reproductive Hormones During Sustained Administration of Kisspeptin","The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.","KisspeptPump","Inclusion criteria:\n\n* Aged 18-60 years old\n* Ability to give informed consent\n* Secondary hypogonadism (or healthy participant)\n\nExclusion criteria:\n\n* anaemia\n* medical problems such as severe heart, kidney or liver disease\n* blood donation in the last three months or intention to donate blood within 3 months of the end of the study\n* needle phobia\n* Poor venous access\n* Active psychiatric illness\n* Severe allergies\n* Impaired ability to provide full consent to take part in the study\n* Current alcohol or illicit drug dependence\n* Current pregnancy or breast feeding\n* Plans to conceive within 3 months of starting the study (barrier contraception must be used during and for 3 months after the end of the study)\n* Arthritis or any impairment of hand coordination which would preclude using a hormone pump",true,"ALL","18 Years","60 Years",{"count":93,"type":94},76,"ESTIMATED","INTERVENTIONAL",[97],"NA","We want to find out what happens to reproductive hormone levels; Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone and oestradiol when kisspeptin is administered to people for a period of 8 days each month, using either placebo (saline) or kisspeptin in doses of 0.1, 0.3 or 1.0 nmol\u002Fkg\u002Fhour.",[100,101],"Fertility Disorders","Hypothalamic Dysfunction",[103,104,105],"Infertility","Kisspeptin","Reproductive hormones","2024-09-09",{"date":108,"type":109},"2024-09-19","ACTUAL",{"date":111,"type":109},"2014-04-02",{"date":113,"type":94},"2027-11-30",{"name":5,"class":6},1]