[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-hypothalamic-amenorrhea-fha\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-hypothalamic-amenorrhea-fha":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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 (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","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 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)",[28],"Functional Hypothalamic Amenorrhea (FHA)",[30,31,32,33],"Secondary amenorrhea","Hypothalamic-Pituitary-Ovarian (HPO) axis","Group I ovulation disorder","Hypogonadotropic hypogonadal anovulation","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":38},"2026-03-11",{"date":42,"type":22},"2027-12-08",{"name":44,"class":45},"Regeneron Pharmaceuticals","INDUSTRY",8,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100638662","effects-of-resistance-training-on-women-with-functional-hypothalamic-amenorrhea-100638662","NCT07612735","Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea","Impact of Strength Training on Mental Health and Physical Fitness in Women With Functional Hypothalamic Amenorrhea","Inclusion Criteria:\n\n* General Profile: Active women aged 18 to 35 years.\n* FHA Group: Clinical diagnosis of Functional Hypothalamic Amenorrhea, defined as the absence of menstruation for at least three consecutive months not attributable to other endocrine disorders.\n* Control Group (EU): Eumenorrheic women with regular ovulatory cycles lasting between 24 and 35 days during the previous six months.\n* Commitment: Agreement to participate in a supervised 8-week resistance training program and provision of medical documentation confirming menstrual status.\n\nExclusion Criteria:\n\n* Hormonal Status: Current use of any hormonal contraceptives.\n* Medical Conditions: Diagnosed endocrine disorders such as Polycystic Ovary Syndrome (PCOS), hyperandrogenism, or thyroid dysfunction.\n\nPregnancy: Current pregnancy.\n\n* Physical Activity History: Engagement in any structured resistance training program during the three months prior to the start of the intervention.\n* General Health: Any medical condition that could interfere with the study protocol or the ability to perform physical exercise.",true,{"count":56,"type":22},28,[58],"NA","Functional hypothalamic amenorrhea (FHA) is a condition where women lose their menstrual periods, typically due to a combination of stress and insufficient calorie intake to fuel their daily physical activity (low energy availability). Standard medical advice often requires these women to completely stop exercising to recover their energy balance and hormones. However, this \"complete rest\" approach can cause severe anxiety for active individuals and removes the necessary mechanical loading that keeps bones strong.\n\nThis study evaluates the safety and effectiveness of an 8-week supervised resistance training (weightlifting) program as a realistic alternative treatment for active women with FHA. The researchers compare a group of women experiencing FHA to a control group of women with regular menstrual cycles. Over the 8 weeks, participants complete three moderate-intensity, full-body weightlifting sessions per week.\n\nThe primary goal is to determine if women with FHA can successfully recover their menstrual cycles while continuing to lift weights. Additionally, the study monitors changes in muscle strength, jumping performance, body composition, resting heart rate, and psychological well-being. Ultimately, this study aims to provide healthcare providers and coaches with evidence-based strategies that allow female athletes to safely maintain their athletic identity and physical health during recovery.",[61,28,62,63],"Amenorrhea","Low Energy Availability","Relative Energy Deficiency in Sport","NOT_YET_RECRUITING","2026-05-22",{"date":67,"type":38},"2026-05-29",{"date":69,"type":22},"2026-05-15",{"date":71,"type":22},"2026-07-25",{"name":73,"class":74},"Catholic University of Murcia","OTHER",1]