[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Freya Biosciences ApS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100629998","phase-2-chlorhexidine-andor-metronidazole-plus-fb301-pre-treatment-trial-100629998",false,"NCT07481955","Chlorhexidine and\u002For Metronidazole Plus FB301 Pre-treatment Trial","Open-label Safety and Efficacy Trial of Chlorhexidine and\u002For Metronidazole Pre-treatment Followed by FB301 in Women With Bacterial Vaginosis","1. Premenopausal women aged 18 to 45 years of age inclusive, at the time of signing the informed consent.\n2. Participants with an untreated suspected or confirmed symptomatic BV presenting with characteristic vaginal discharge and\u002For fishy odor confirmed by Gram stain of the vaginal specimen having a Nugent Score of equal or above 7 at the screening visit.\n3. Participant is otherwise in good physical and mental health, as determined by the investigator\n4. BMI up to 37 kg\u002Fm2 (inclusive)\n5. Premenopausal female patients Using oral, transdermal (patches), or injectable\u002Fimplantable contraceptives or hormonal IUS (non-hormonal IUD is not allowed) within the last 3 months prior to screening must be willing not to change their method of contraception during the trial.OR Not using any hormonal method of contraception must be willing not to start any other method of contraception during the trial. They must use condoms after the period in which no sexual activity is allowed, i.e., following the primary evaluation timepoint\n6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n7. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives\n8. Willing to be asked questions about reproductive\u002Fsexual activity and use of vaginal products.\n9. Willing to provide and self-collect cervicovaginal secretions and vaginal swab samples at the clinic\n10. Willing to undergo vaginal cleansing and treatment procedures, including selfadministration of IMP, where required, at home.\n11. Willing to abstain from vaginal intercourse, following the first FB301 treatment until the primary evaluation timepoint\n12. Willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the Investigator following the first FB301 treatment until the primary evaluation timepoint\n13. Willing and able to comply with trial procedures and attending scheduled visits.\n14. No changes in medical conditions or prior\u002Fconcomitant therapy also regarding adherence to sexual behavior and contraceptive\u002Fbarrier requirements.\n\nExclusion Criteria:\n\n1. Known immunodeficiency conditions, including drug induced.\n2. Contraindication to metronidazole or chlorhexidine.\n3. Any known condition requiring regular use of antibiotics, which would suggest the likely requirement for antibiotic treatment during the trial.\n4. Any social, medical, or psychiatric condition that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial requirements or might interfere with the objectives of the trial.\n5. History of drug or alcohol abuse that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial or would complicate interpretation of data from participation.\n6. History of gynecological cancers, gynecological conditions, or surgical gynecological medical history which, in the opinion of the Investigator, precludes participation.\n7. Abnormal finding on the physical examination or gynecological examination or any other condition which, in the opinion of the Investigator, precludes participation.\n8. Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or active Herpes simplex \\[including PCR test positive\\]).\n9. Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response.\n10. Participants taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks or 5 half-lives (whichever is longer) before the start of trial treatment (unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial).\n11. Receiving treatment involving investigational drugs. Any previous investigational drug must have been completed at least 30 days prior to screening in this trial.\n12. Systemic and\u002For vaginally applied antibiotic use within the last 30 days prior to screening.\n13. Participants who are currently receiving antibacterial therapy unrelated to BV.\n14. Clinical laboratory test results which are clinically unacceptable at screening. Any clinically significant abnormal urinalysis should be repeated. If then confirmed abnormal and clinically significant, participant should be excluded. Any clinically significant out of range chemistry or hematology values should exclude the participant.\n15. Positive serum HBsAg (other than vaccination related), HCV and HIV antibody tests at screening.\n16. Positive test for Treponema pallidum (syphilis).\n17. Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).\n18. Aural body temperature of \\\u003C 35.5 or \\> 37.6°C at screening\n19. Pregnant, breastfeeding, has been pregnant within the last 2 months, or wishes to become pregnant within the next 6 months. Egg donation during the trial is not permitted.\n20. Use of a copper IUD (intrauterine device) within 12 weeks of screening. (Hormonal IUDs are permitted.)\n21. Use of probiotics, prebiotics or symbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods)\n22. Donation of more than 100 mL whole blood or plasma within 4 weeks before start of treatment or more than 500 mL of whole blood 3 months before start of treatment or intended blood donation during the trial.\n23. History of alcohol or substance dependency.\n24. Employee of the Sponsor, the CRS Group, or other CRO involved in the clinical trial.\n25. Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.\n\n    \\-","FEMALE","18 Years","45 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an oral antibiotic (metronidazole), or both.\n\nThe main question it aims to answer is:\n\nDoes treatment with FB301, with or without pre-treatment using a vaginal antiseptic (chlorhexidine) or an oral antibiotic (metronidazole), change the balance of vaginal bacteria, measured by the proportion of two key bacteria (Lactobacillus crispatus and Lactobacillus jensenii), between the start of treatment and follow-up visits over the next 10 weeks?\n\nResearchers will compare participants randomly assigned to 4 different groups:\n\n* Group 1 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n* Group 2 will receive FB301for 15 days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n* Group 3 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive FB301 for an additional 15-days following a vaginal cleanse with chlorhexidine (antiseptic solution) on the first day only.\n* Group 4 will receive just FB301for 15 days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n\nParticipants will:\n\n* Attend the study centre for up to 6 visits\n* Provide vaginal swab samples at up to 6 visits\n* Provide vaginal secretion samples using a menstrual disc at up to 4 visits\n* Have blood samples taken at up to 6 visits\n* Receive the study treatments for the randomly assigned group over two consecutive menstrual cycles.",[27],"Bacterial Vaginosis (BV)","NOT_YET_RECRUITING","2026-03-18",{"date":31,"type":32},"2026-03-20","ACTUAL",{"date":34,"type":21},"2026-03-16",{"date":36,"type":21},"2027-04-21",{"name":38,"class":39},"Freya Biosciences ApS","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100627779","phase-2-effect-of-fb301-on-vaginal-bacterial-profile-in-women-with-asymptomatic-vaginal-dysbiosis-undergoing-a-mock-frozen-embryo-transfer-cycle-100627779","NCT07453069","Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle","A Randomized, Double-blind, Three Arm, Multi-center Phase 2 Study to Investigate the Molecular Efficacy and Safety of FB301\u002FChlorhexidine Compared With FB301\u002FSham and Placebo\u002FSham in a Mock FET Cycle in Female Participants 18-40 Years of Age With Asymptomatic Vaginal Molecular Dysbiosis Planning to Undergo a Frozen Embryo Transfer (FET) Cycle","Inclusion Criteria:\n\n1. Able to understand the study and sign a consent form.\n2. Is a woman aged 18 to 40 years.\n3. Still has regular menstrual periods (pre-menopausal).\n4. Has had at least one previous frozen embryo transfer (FET) that did not result in pregnancy within the past 3 years, and this was not due to either male infertility or blocked \u002Fdamaged fallopian tubes.\n5. Planning to have a frozen embryo transfer (FET) using one good-quality embryo (grade 3BB or higher) and are considered medically suitable to proceed.\n6. Willing to have only one embryo transferred during the study cycle.\n7. A vaginal swab taken at the first study visit shows a specific vaginal microbiome imbalance required for this study (vaginal molecular dysbiosis).\n8. An ultrasound scan shows no problems with uterus or pelvis that would prevent pregnancy or greatly reduce the chance of pregnancy.\n9. Recent fertility blood tests (within the last 6 months) show:\n\n   * FSH less than 12 IU\u002FL\n   * AMH greater than 1 ng\u002FmL\n10. Body mass index (BMI) is between 18 and 38 kg\u002Fm².\n11. From the first study treatment until the mock FET cycle, agrees to:\n\n    * Avoid vaginal intercourse or use condoms (without spermicide or lubricant),\n    * Avoid swimming or hot tubs,\n    * Avoid using tampons, menstrual cups, sex toys, vaginal cleansers, lubricants, or other vaginal products unless approved by the study team.\n12. Willing to answer questions about sexual and reproductive activity during the study.\n13. Willing to provide vaginal swab samples at the clinic.\n14. Willing to receive the first study treatment in the clinic and use the study treatment at home as instructed.\n15. Screening blood tests are negative for hepatitis B, hepatitis C, HIV, and syphilis.\n16. Willing to attend all study visits and follow-up assessments and provide information about pregnancy and newborn health outcomes.\n\nExclusion Criteria:\n\n1. History of three or more failed frozen embryo transfers (FET) in the past 3 years.\n2. Have a condition that weakens the immune system (such as uncontrolled diabetes, active cancer, or an organ transplant).\n3. Currently taking medications that suppress the immune system (such as systemic steroids, biologics, chemotherapy, or transplant medications).\n4. Is already pregnant before completing the mock FET cycle.\n5. Test positive for a sexually transmitted infection (such as chlamydia, gonorrhea, Mycoplasma genitalium, or Trichomonas vaginalis).\n6. Current vaginal yeast infection that requires treatment.\n7. YCannot safely take the hormone medications required for a frozen embryo transfer (such as estradiol or progesterone).\n8. Use of intravaginal progesterone gels or solutions.\n9. Needs regular antibiotics or are likely to require antibiotics during the study.\n10. Has taken oral, injectable, or vaginal antibiotics within 30 days before screening.\n11. History of gynecological cancer or other significant gynecological condition that would make participation unsafe.\n12. Has a medical condition that would make participation unsafe or difficult.\n13. Has an unstable medical or psychiatric condition that could make it difficult to follow study requirements.\n14. Has any other condition that could interfere with participation.","40 Years",{"count":50,"type":21},30,[24],"The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).\n\nThe main question it aims to answer is:\n\n• Does treatment with FB301 during a mock FET cycle change the proportion of participants who meet the predefined vaginal bacterial threshold compared with placebo?\n\nResearchers will compare:\n\n* FB301 given after an initial vaginal cleansing with chlorhexidine (an antiseptic solution),\n* FB301 given after an initial vaginal cleansing with saline (saltwater), and\n* A placebo capsule given after an initial vaginal cleansing with saline to determine whether these approaches affect vaginal bacterial composition and pregnancy outcomes.\n\nParticipants will take study treatment for 15 days during a \"mock\" FET cycle. In a mock cycle, participants receive the hormones needed to prepare the uterus for embryo transfer, but no embryo is transferred. After completing the mock cycle, participants will proceed with their planned frozen embryo transfer and will be followed during pregnancy until birth.\n\nParticipants will:\n\n* Undergo a vaginal cleansing before receiving the first dose of FB301 or placebo\n* Provide vaginal swab samples at up to 5 study visits\n* Attend the study centre for up to 8 visits and participate in up to 4 follow-up phone calls\n* Complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle\n\nParticipants who become pregnant will be followed until birth.",[54],"Vaginal Dysbiosis","2026-03-03",{"date":57,"type":32},"2026-03-05",{"date":59,"type":21},"2026-04-15",{"date":61,"type":21},"2027-09-30",{"name":38,"class":39},""]