[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533202":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":70,"collaborators":72,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":50,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":50,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":58,"whyStopped":50,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"International Research Training Group 2804","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"NC follicular","EXPERIMENTAL","Naturally cycling, healthy women in the follicular menstrual cycle phase.",[13,14],"Drug: Intranasal oxytocin administration","Drug: Intranasal placebo administration",{"label":16,"type":10,"description":17,"interventionNames":18},"NC luteal","Naturally cycling, healthy women in the luteal menstrual cycle phase.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"OC combined","Healthy women taking combined oral hormonal contraceptives.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"OC progestogen-only","Healthy women taking progestogen-only oral hormonal contraceptives.",[13,14],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Intranasal oxytocin administration","24 international units (IU) of Syntocinon, nasal spray solution; 1 ml nasal spray contains 40 I.U. oxytocin (equivalent to 67 mcg). One spray hub (0.1 ml) contains 4 I.U. oxytocin (equivalent to 6.7 mcg).",[9,16,20,24],[34],"Syntocinon",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Intranasal placebo administration","Nasal spray solution; Placebo will be administered as the placebo controlled condition.",[9,16,20,24],[40],"Placebo",[42],{"name":43,"affiliation":44,"role":45},"Manfred Hallschmid, Professor","Institute of Medical Psychology and Behavioural Neurobiology","PRINCIPAL_INVESTIGATOR",[47,52],{"name":43,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","+49 7071 29 88925",null,"manfred.hallschmid@uni-tuebingen.de",{"name":53,"role":48,"phone":50,"phoneExt":50,"email":54},"Johannes Klaus, MD","Johannes.Klaus@med.uni-tuebingen.de",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":50},"University of Tuebingen; Department of Psychiatry & Psychotherapy; Institute of Medical Psychology and Behavioural Neurobiology","RECRUITING","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":65,"coordinates":66},"Point",[67,68],9.05222,48.52266,{"lat":68,"lon":67},{"type":71,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[73,75,77],{"name":74,"class":6},"University Hospital Tuebingen",{"name":76,"class":6},"German Research Foundation",{"name":78,"class":6},"Uppsala University","100533202","oxytocin-and-reward-processing-in-women-100533202",false,"NCT06222749","Oxytocin and Reward Processing in Women","The Role of Oxytocin in Reward Processing Across the Menstrual Cycle and With Oral Contraceptive Use","Inclusion Criteria:\n\n* Body-mass index (BMI): 18-28 kg\u002Fm2\n* Sex: female (since birth)\n* Normal or corrected vision\n* Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC)\n* NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation\n* OC: No hormonal contraception for at least 4 months, regular intake of OC pill\n\nExclusion Criteria:\n\n* No German language fluency (due to German language test content)\n* Smoking\n* Medication taken within the last 6 weeks (except for OCs in the respective group)\n* Current neurological or psychiatric disease (anamnestic survey)\n* Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure)\n* Pregnancy, delivery and lactation (current and within the last year; anamnestic survey, current pregnancy test)\n* Premenstrual dysphoric disorder (PMDD), endometriosis or polycystic ovary syndrome (PCOS)\n* Shift work\n* NC: Any kind of hormonal treatment or contraception\n* OC: Any kind of hormonal treatment or contraception (except OCs)\n* Contraindication for MRI:\n* Non-removable metal objects on or in the body\n* Tattoos (if MRI-incompatible according to expert guidelines)\n* Pathological hearing or increased sensitivity to loud noise\n* Claustrophobia\n* Operation less than three months ago\n* Neurological disease or injury\n* Moderate or severe head injury\n* Intake of antidepressants or neuroleptics\n* Restricted vision",true,"FEMALE","18 Years","40 Years",{"count":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"NA","Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Oxytocin receptors are present in brain regions associated with the processing of rewards, e.g., ventral tegmental area (VTA), nucleus accumbens (NAcc) and nucleus stria terminalis.\n\nPrevious studies indicate that oxytocin interacts with sex hormones such as estradiol in a sex-specific manner. Despite known sex differences in oxytocin function, most studies i.e., on the metabolic effects of oxytocin in humans have so far focused on young, healthy men.\n\nIntranasal oxytocin administration has emerged as a method to experimentally investigate central nervous effects of oxytocin in the absence of relevant side effects.\n\nIn the proposed study the investigators aim to systematically investigate the acute effect of intranasal oxytocin on reward processing in relation to circulating and synthetic sex hormones in healthy, naturally cycling women and in women taking hormonal oral contraceptive pills. The investigators will administer 24 international units (IU) of intranasal oxytocin vs. placebo and investigate neural correlates in a 3T MRI scanner including functional imaging during a reward processing task, changes in brain anatomy and connectivity. Additionally, metabolic functions, eating behavior and changes in mood and wellbeing will be assessed and blood will be drawn to assess parameters of hormonal and metabolic status.",[98,99],"Menstrual Cycle","Hormonal Contraception",[101,102,103,104,105,106,107,108,109,110,111,112,113,114],"Oxytocin","Intranasal oxytocin","magnetic resonance imaging","MRI","fMRI","energy homeostasis","metabolism","reward processing","motivation","menstrual cycle","hormonal contraceptives","sex hormones","eating behavior","women's mental health","2024-02-27",{"date":117,"type":118},"2024-02-28","ACTUAL",{"date":120,"type":118},"2024-02-16",{"date":122,"type":92},"2026-12-31",{"name":5,"class":6},1]