[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Angelica Lindén Hirschberg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100632142","phase-3-immunomodulatory-therapy-to-restore-ovarian-function-and-improve-fertility-in-women-with-autoimmune-premature-ovarian-insufficiency-100632142",false,"NCT07509840","Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency","Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency - Double-blind, Placebo-contrelled, Randomized Study.","REFINE","Inclusion Criteria:\n\n1. The subject has given their written consent to participate in the trial\n2. Autoimmune POI (FSH \\> 25 IU\u002FL) including the presence of oligo\u002Famenorrhea lasting at least 4 months, and elevated FSH levels (FSH \\> 25 IU\u002FL) confirmed on two separate occasions, with measurements taken at least 4 weeks apart and Addison's disease or ab positivity for 21-hydroxylase or other relevant autoantibodies (SCC, 17-OH, NALP5)\n3. 18-38 years of age\n4. Body mass index between 19-30\n5. Willing to use effective non-hormonal contraceptive (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) method during the 18-month study period\n\nExclusion Criteria:\n\n1. Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)\n2. Active, severe infection or JCV positivity\n3. Active hepatitis B infection\n4. Severe immunosuppression\n5. Severe cardiac disease\n6. Cancer\n7. Benign tumours of the hypothalamus, pituitary, or ovarian pathology\n8. Vaginal bleeding of unknown etiology\n9. Hormone replacement therapy within four weeks prior study entry\n10. Pregnant or lactating women\n11. Concurrent treatment with other immunosuppressive drugs\n12. Any vaccination within 4 weeks of infusion of study medication\n13. Severe psychiatric disorder\n14. Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation\n15. Active thrombolic disorder (contraindicated for Ovirelle)\n16. Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran)\n\n    \\-","FEMALE","18 Years","38 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Several autoimmune diseases such as Addison's disease are associated with failing ovarian function, known as premature ovarian insufficiency (POI), which can lead to early menopause and reduced fertility.The underlying cause of POI in these women is considered to be an immunological attack on the ovaries that causes them to not respond to hormonal stimulation from the brain. Hormone replacement effectively counteracts menopausal symptoms, but today there is no treatment to normalize or even improve fertility. As a patient with POI and an autoimmune diagnosis and the desire to become pregnant, you are asked to participate in the study. The aim of this study is to investigate whether immunomodulatory therapy can improve and ideally normalize ovarian function in women of childbearing age with autoimmune disease and proven POI. Patients with a male partner and a desire for children and who respond positively to the first ovarian stimulation will be offered in vitro fertilization (IVF) and will thus be allowed to complete the study. Other participating patients will undergo a total of three ovarian stimulations and treatment with first two infusions of the registered drug rituximab or placebo (inactive agent) and later two additional infusions where all patients receive rituximab. The first two infusions with rituximab or placebo are double-blind, which means that neither you nor the study staff know what you have received. Follow-up takes place up to 12 months after the last infusion.",[28],"Autoimmune Prematur Ovarian Insuffience","RECRUITING","2026-03-29",{"date":32,"type":33},"2026-04-03","ACTUAL",{"date":35,"type":33},"2026-02-12",{"date":37,"type":22},"2031-12-31",{"name":39,"class":40},"Angelica Lindén Hirschberg","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100484337","phase-3-micronized-progesterone-versus-norethisterone-acetate-in-combination-with-estrogen-as-menopausal-hormone-therapy-100484337","NCT05586724","Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy","Safety of Oral Micronized Progesterone Versus Norethisterone Acetate in Continuous Combination With Oral Estrogen as Menopausal Hormone Therapy - a Double-blind Randomized Study- PROBES Study (Progesterone Breast Endometrial Safety Study)","Inclusion Criteria:\n\n* Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH \\> 40 IE\u002FL) with climacteric symptoms (sweating, hot flush and\u002For sleep problems) that adversely affect the quality of life\n* Age 45-60 years\n* BMI \\> 19 kg\u002Fm2 and ≤ 32 kg\u002Fm2\n* Intact uterus\n* In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert\n* Previous history or risk factors for endometrial cancer or hyperplasia or abnormal\u002Fproliferative endometrial biopsy at baseline\n* Vaginal bleeding\n* Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2 diabetes, asthma and hypothyroidism\n* History or presence of or risk factor for cardiovascular disease including thromboembolic disorder or cerebrovascular disease\n* History or presence of liver and gallbladder disease, familial hyperlipidemia, epilepsy or classical migraine with aura\n* History or presence of clinically significant depression or other psychiatric disorder that might in anyway compromise the performance of the trial or undermine its scientific validity\n* Porphyria, Systemic lupus erythematosus and otosclerosis\n* Current use of MHT or local estrogen treatment\n* Alcohol and\u002For drug abuse\n* Clinically significant findings on physical and\u002For gynecological examination at baseline\n* Hypersensitivity to any of the study treatments","45 Years","60 Years",{"count":51,"type":22},520,[25],"About one third of all women during menopausal transition have significant climacteric symptoms with considerable impact on quality of life. Meta-analysis has shown a beneficial risk profile with menopausal hormone therapy (MHT) for women 50 to 60 years. Still, there is a great need to find safe MHT able to control excessive endometrial stimulation by estrogen without stimulatory effects on the breast by the combination of estrogen\u002Fprogestogen. Recent observational studies indicate a lower risk for breast cancer using micronized progesterone (mP) combined with estrogen but increased risk of endometrial cancer than by standard MHT. In a randomized trial, the balance between benefits and risks of mP vs. progestogens (norethisterone (NETA)) in combination with estrogen will be explored. For apparent reasons, long-term largescale clinical trials with endometrial and breast cancer as the primary endpoints, are not feasible. However, much knowledge can be obtained using relevant surrogate markers. Mammographic breast density is a strong risk factor for breast cancer, and endometrial hyperplasia is a strong risk factor for endometrial cancer. The primary objective is to compare the effects of one year treatment with mP versus progestogen, in combination with estradiol on mammographic breast density. Furthermore, to evaluate the effect of one year treatment with mP in continuous combination with estradiol on endometrial pathology (hyperplasia and cancer).",[55],"Menopausal Symptoms",[57,58,59,60,61,62],"Menopausal hormone therapy","Climacteric symptoms","Progesterone","Progestogens","Breast safety","Endometrial safety","2024-06-02",{"date":65,"type":33},"2024-06-04",{"date":67,"type":33},"2022-03-15",{"date":69,"type":22},"2027-12",{"name":39,"class":40},1,""]