[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224490":3,"trial-entities:NCT07224490":89,"trial-summary:NCT07224490":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":66,"locations":68,"central_contacts":84,"overall_officials":86,"references":87,"see_also_links":88},"NCT07224490","565179","Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease","RECRUITING","2030-05","2026-07","2026-07-13","2026-03-10","Stephanie B. Seminara, MD","OTHER",true,"The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.","Delivery of Interventions:\n\n* Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg\u002Fkg\n* Blood sampling before and after administration of kisspeptin (two timepoints total)",[18,19,20,21],"Reproductive Disorder","Neurodegeneration","SARS-CoV 2","Long COVID",[23,19,20,24,21],"Reproductive disorder","Kisspeptin","INTERVENTIONAL",[27],"PHASE1",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Kisspeptin 112-121","Single bolus of kisspeptin",[37],"Kisspeptin administration",[39],"Metastin 45-54",[41],{"measure":42,"description":43,"timeFrame":44},"Difference in mean luteinizing hormone (LH) amplitude between cases and controls","Difference between cases and controls of mean LH amplitude in response to kisspeptin","Day of study visit (one to two hours)",[],"ALL","18 Years","60 Years",false,{"inclusion":51,"exclusion":57,"raw_text":65},[52,53,54,55,56],"Female (ages 18-45 years) or Male (ages 18-60 years)","No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration","For women, negative serum hCG pregnancy test","For cases, diagnosis of post-covid-19 syndrome","For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome",[58,59,60,61,62,63,64],"Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in\u002Fcompletion of the protocol or the interpretation of results","Active use of illicit drugs (not including marijuana)","For women,","Pregnant","Trying to become pregnant during protocol participation","Breast feeding","Surgical or natural menopause","Inclusion Criteria\n\n* Female (ages 18-45 years) or Male (ages 18-60 years)\n* No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration\n* For women, negative serum hCG pregnancy test\n* For cases, diagnosis of post-covid-19 syndrome\n* For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome\n\nExclusion Criteria\n\n* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in\u002Fcompletion of the protocol or the interpretation of results\n* Active use of illicit drugs (not including marijuana)\n* For women,\n* Pregnant\n* Trying to become pregnant during protocol participation\n* Breast feeding\n* Surgical or natural menopause",[67],"ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Study Coordinator","CONTACT","617-643-2308","MGHKisspeptinResearch@partners.org",{"lat":82,"lon":83},42.35843,-71.05977,[85],{"name":77,"role":78,"phone":79,"email":80},[],[],[],{"nct_id":4,"conditions":90,"biomarkers":93},[91,92],"Post-Acute Sequelae of COVID-19","Severe Acute Respiratory Syndrome",[],{"nct_id":4,"found":14,"summary":95,"prompt_version":105},{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study comparing responses to kisspeptin in different groups. It plans to enroll 40 participants.","completed","Kisspeptin for Reproductive Disorders and Long COVID","This study is looking at how a substance called kisspeptin 112-121 affects the body, specifically how it influences the reproductive system. Researchers want to compare the response to kisspeptin in people with and without conditions like reproductive disorders, neurodegeneration, SARS-CoV-2 (the virus that causes COVID-19), and Long COVID. You might be able to join if you are a woman aged 18-45 or a man aged 18-60, and you're not currently taking medications that affect your reproductive hormones. The main goal is to see if there's a difference in how much luteinizing hormone (LH), a reproductive hormone, changes after receiving kisspeptin in people with these conditions compared to healthy individuals. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","The primary endpoint is measured at the day of the study visit (one to two hours).",124,"You would receive a single injection of kisspeptin and have blood drawn before and after the injection (two times total) during a one to two-hour study visit.","Not stated in the trial record.",[34],"v2"]