[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fha\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fha":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100611079","phase-2-a-study-to-investigate-mibavademab-in-adult-women-with-functional-hypothalamic-amenorrhea-100611079",false,"NCT07235917","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","KYRIAD","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 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 \\\u003C23% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening\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, as described in the protocol\n3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian conditions (eg, absence of an ovary, presence of large polycystic ovaries i.e. greater than 10 cc) 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), as described in the protocol\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","FEMALE","18 Years","40 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is researching an experimental drug called mibavademab (also called \"study drug\"). The study is focused on participants 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 study drug less effective or could lead to side effects)",[28,29],"Functional Hypothalamic Amenorrhea","FHA",[31,32,33,34,35,36,37,38,39,40,41,42,43],"Secondary amenorrhea","Hypothalamic Pituitary Ovarian axis","HPO","Group I ovulation disorder","Hypogonadotropic hypogonadal anovulation","Gonadotropin Releasing Hormone Deficiency","GnRH Suppression","Amenorrhea","Female Infertility","Hypoestrogenism","Estrogen Deficiency","Menstrual Dysfunction","Menstrual Cycle Disturbance","RECRUITING","2026-09-28",{"date":47,"type":48},"2026-10-01","ACTUAL",{"date":50,"type":48},"2026-03-11",{"date":52,"type":22},"2028-05-17",{"name":54,"class":55},"Regeneron Pharmaceuticals","INDUSTRY",11]