[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07235917":3,"trial-entities:NCT07235917":198,"trial-summary:NCT07235917":202},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":48,"sex":94,"minimum_age":95,"maximum_age":96,"healthy_volunteers":15,"eligibility_criteria":97,"std_ages":101,"locations":103,"central_contacts":183,"overall_officials":189,"references":193,"see_also_links":194},"NCT07235917","R4461-FHA-2485","A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea","A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea","RECRUITING","2027-12-08","2026-07","2026-07-14","2026-03-11","Regeneron Pharmaceuticals","INDUSTRY",false,"This study is researching an experimental drug called mibavademab (also called \"study drug\"). The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly.\n\nThe aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety.\n\nThe study is looking at several other research questions, including:\n\n* Whether the drug helps bone health\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",null,[19],"Functional Hypothalamic Amenorrhea (FHA)",[21,22,23,24],"Secondary amenorrhea","Hypothalamic-Pituitary-Ovarian (HPO) axis","Group I ovulation disorder","Hypogonadotropic hypogonadal anovulation","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},34,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Mibavademab","Administered per the protocol",[35],[39],"REGN4461",{"type":41,"name":42,"description":36,"armGroupLabels":43},"OTHER","Placebo",[42],[45],{"measure":46,"timeFrame":47},"Change from the highest serum estradiol observed during a 28-day period","Baseline to month 6",[49,51,54,57,60,62,64,66,69,71,73,75,77,79,81,83,86,88,90,92],{"measure":50,"timeFrame":47},"Change from the mean serum estradiol observed during a 28-day period",{"measure":52,"timeFrame":53},"Occurrence of menses followed by mid-cycle serum estradiol ≥200 pg\u002Fml and mid-luteal serum progesterone ≥7.9 ng\u002Fml","At month 6",{"measure":55,"timeFrame":56},"Change in the highest serum estradiol","Baseline through 6 months",{"measure":58,"timeFrame":59},"Occurrence of serum estradiol ≥200 pg\u002Fml","Through 6 months",{"measure":61,"timeFrame":59},"Number of ovulatory menstrual cycles",{"measure":63,"timeFrame":59},"Number of menses with mid-luteal serum progesterone ≥7.9 ng\u002Fml and midluteal estradiol ≥100 pg\u002Fml",{"measure":65,"timeFrame":59},"Number of menstrual cycles",{"measure":67,"timeFrame":68},"Percent change in Bone Mineral Density (BMD) at the lumbar spine, as measured by Dual X-ray Absorptiometry (DXA)","Baseline to 6 months",{"measure":70,"timeFrame":68},"Absolute change in BMD at the lumbar spine, as measured by DXA",{"measure":72,"timeFrame":68},"Percent change in Bone Mineral Content (BMC) at the lumbar spine, as measured by DXA",{"measure":74,"timeFrame":68},"Absolute change in BMC at the lumbar spine, as measured by DXA",{"measure":76,"timeFrame":68},"Percent change in BMD at the lumbar spine, as measured by DXA in participants with baseline lumbar spine BMD Z-score \u003C-1",{"measure":78,"timeFrame":68},"Absolute change in BMD at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score \u003C-1",{"measure":80,"timeFrame":68},"Percent change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score \u003C-1",{"measure":82,"timeFrame":68},"Absolute change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score \u003C-1",{"measure":84,"timeFrame":85},"Occurrence of Treatment Emergent of Adverse Events (TEAEs)","Up to day 280",{"measure":87,"timeFrame":85},"Severity of TEAEs",{"measure":89,"timeFrame":85},"Concentrations of total mibavademab in serum",{"measure":91,"timeFrame":85},"Occurrence of Anti-Drug Antibodies (ADA) to mibavademab",{"measure":93,"timeFrame":85},"Magnitude of ADA to mibavademab","FEMALE","18 Years","40 Years",{"inclusion":98,"exclusion":99,"raw_text":100},[],[],"Key Inclusion Criteria:\n\n1. Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea\n2. Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol\n3. Has a Body Mass Index (BMI) ≥18.5 and \\\u003C25 kg\u002Fm\\^2 at screening, or BMI ≥25 to \\\u003C30 kg\u002Fm\\^2 at screening AND percentage of body fat \\\u003C20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)\n2. Has blood estradiol ≥50 pg\u002FmL or blood progesterone ≥1 ng\u002FmL at screening\n3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis\n4. Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism)\n5. Polycystic ovarian morphology with an ovarian volume \\>10 cc on TransVaginal UltraSound (TVUS) \\[or TransAbdominal Pelvic Ultrasound (TAPU) if applicable\\] at baseline\n6. Presence of follicle ≥17 mm, evidence of ruptured follicle, and\u002For evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline\n\nNOTE: Other protocol-defined Inclusion\u002FExclusion criteria apply",[102],"ADULT",[104,113,121,129,137,145,153,160,168,176],{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":109,"geoPoint":110},"Arensia Exploratory Medicine Clinic","Phoenix","Arizona","85015","United States",{"lat":111,"lon":112},33.44838,-112.07404,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":109,"geoPoint":118},"Focus Clinical Research","West Hills","California","91307",{"lat":119,"lon":120},34.19731,-118.64398,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":109,"geoPoint":126},"Yale University School of Medicine","New Haven","Connecticut","06510",{"lat":127,"lon":128},41.30815,-72.92816,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":109,"geoPoint":134},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"lat":135,"lon":136},30.33218,-81.65565,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":109,"geoPoint":142},"Oregon Health and Science University (OHSU)","Portland","Oregon","97239",{"lat":143,"lon":144},45.52345,-122.67621,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":109,"geoPoint":150},"OBGYN Associates of Erie","Erie","Pennsylvania","16507",{"lat":151,"lon":152},42.12922,-80.08506,{"facility":154,"status":8,"city":155,"state":148,"zip":156,"country":109,"geoPoint":157},"Penn State Health Milton South Hershey Medical Center","Hershey","17033",{"lat":158,"lon":159},40.28592,-76.65025,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":109,"geoPoint":165},"Zillan Clinical Research","Houston","Texas","77082",{"lat":166,"lon":167},29.76328,-95.36327,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":109,"geoPoint":173},"University of Virginia School of Medicine","Charlottesville","Virginia","22908",{"lat":174,"lon":175},38.02931,-78.47668,{"facility":177,"status":8,"city":178,"state":171,"zip":179,"country":109,"geoPoint":180},"Tidewater Clinical Research - Tidewater Physicians for Women","Norfolk","23502",{"lat":181,"lon":182},36.84681,-76.28522,[184],{"name":185,"role":186,"phone":187,"email":188},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[190],{"name":191,"affiliation":13,"role":192},"Clinical Trial Management","STUDY_DIRECTOR",[],[195],{"label":196,"url":197},"Related Info","https:\u002F\u002Fkyriadstudy.com\u002F",{"nct_id":4,"conditions":199,"biomarkers":201},[200],"Hypothalamic amenorrhea, functional",[],{"nct_id":4,"found":203,"summary":204,"prompt_version":214},true,{"design":205,"status":206,"heading":207,"summary":208,"follow_up":209,"word_count":210,"commitments":211,"compensation":212,"drugs_mentioned":213},"This interventional study is testing mibavademab against a placebo. It plans to enroll 34 adult women.","completed","A Study of Mibavademab for Functional Hypothalamic Amenorrhea","This study is investigating an experimental drug called mibavademab for adult women with Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where your brain doesn't send the right signals to your ovaries, causing your periods to stop. The main goal is to see how well mibavademab helps your body produce the hormones needed for ovulation and reproduction, and to check its safety. You might be able to join if you are a woman between 18 and 40 years old, have a diagnosis of FHA, and haven't had a period for at least 3 months. The study is also looking at how mibavademab might affect bone health and what side effects it may cause. The study plans to enroll 34 participants, and its current status is unclear.","The primary endpoint measures changes in a hormone called estradiol from the beginning of the study up to 6 months.",126,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]