[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daré Bioscience, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639976","phase-2-a-study-of-the-preliminary-efficacy-of-dare-hpv-to-treat-high-risk-persistent-human-papillomavirus-hrhpv-100639976",false,"NCT07601074","A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)","A Phase 2a, Multi-Center, Placebo-Controlled, Double-Blinded, Randomized, Dose Ranging Study of the Preliminary Efficacy of DARE-HPV to Treat Persistent High-Risk Human Papillomavirus (HPV) Genital Infection","Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study-specific procedures.\n2. Premenopausal women aged 22-50 years inclusive at the time of screening visit.\n3. Positive result for genital hrHPV (types 16, 18, or 'other') on at least 2 tests over the span of at least 12 months (history of persistent hrHPV infection for at least 12 months), based on review of participant's medical records. The visit 1 screening genital hrHPV test may be the second positive test.\n4. Generally, in good health with no clinically significant disease as determined by the Investigator.\n5. Regular menstrual cycle with an approximate 28-day cycle OR women who are amenorrheic due to effective contraception (such as levonorgestrel intrauterine system, or continuous oral contraception).\n6. Agree to refrain from vaginal douching, insertion of intravaginal devices (e.g., tampons, menstrual cups), and use of condoms for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.\n7. Agree to abstain from all vaginal and oral intercourse for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.\n8. Women at risk of pregnancy must use a highly effective form of birth control (confirmed by the Investigator) for the entire duration of the study. Rhythm methods and consistent use of condoms will not be considered as highly effective methods of birth control. Highly effective forms of birth control include:\n\n   * Heterosexual abstinence\n   * Vasectomized male partner (provided that the male partner is the sole sexual partner of the female participant with childbearing potential and that the vasectomized partner has received medical assessment of the surgical success);\n   * Oral or transdermal combined ethinyl estradiol\u002Fprogestin hormonal contraception associated with inhibition of ovulation;\n   * Oral, injectable or implantable progestogen-only hormone contraception associated with inhibition of ovulation (e.g., Depo-Provera™, Nexplanon, Slynd);\n   * Any effective copper intrauterine device\u002Flevonorgestrel intrauterine system;\n   * Female sterilization by tubal occlusion or bilateral salpingectomy;\n   * Supracervical hysterectomy.\n9. Ability and willingness to attend the necessary visits to the study center.\n10. Ability to comprehend all study related documentation, including written informed consent form, and complete all study-related tasks including daily diary.\n11. Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n\nExclusion Criteria:\n\n1. Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study.\n2. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the participant at risk because of her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.\n3. Cytological abnormality of the uterine cervix defined as LSIL or mild cervical intraepithelial neoplasia (CIN1), or HSIL or moderate (CIN 2) or severe (CIN 3) histology, as proven by cytology or colposcopic biopsy collected within the 12 months prior to screening or cytology at screening.\n4. Pregnant, breastfeeding, or lactating women (WOCBP must have a negative urine pregnancy test at screening and at the start of treatment \\[i.e., Day 1\\]).\n5. Active pelvic infection (positive for gonorrhea or chlamydial infection, positive test and symptoms for bacterial vaginosis, candida vaginitis or trichomonal vaginitis). Participants with positive results can be treated and re-tested once during screening.\n6. Positive result for hepatitis B, hepatitis C antibody or human immunodeficiency virus.\n7. Currently taking systemic immunosuppressants, biologics, intra-vaginal preparations, or any prescription that in the opinion of the Investigator could be a potential safety issue or interfere with the interpretation of the results.\n8. Previous exposure to lopinavir\u002Fritonavir (within 3 months prior to screening), contraindication to the use of lopinavir\u002Fritonavir or known allergy, hypersensitivity, or intolerance to any component of lopinavir\u002Fritonavir excipients.\n9. Recent history (within 3 months prior to screening) of Stevens-Johnson syndrome, erythema multiforme, urticaria, or angioedema.\n10. Receipt of any investigational product within 30 days or 5 half-lives prior to dosing.\n11. Participants who, in the opinion of the Investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular, the study restrictions and risks involved).","FEMALE","22 Years","50 Years",{"count":20,"type":21},118,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days.\n\nThe study will look at two different doses of DARE-HPV and two different treatment durations of 14 and 21 days compared to a placebo group or 14 or 21 days of treatment.",[27,28],"Human Papilloma Virus (HPV)","High-risk Human Papillomavirus Infection",[30,31],"HPV","hrHPV","NOT_YET_RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2027-12",{"name":42,"class":43},"Daré Bioscience, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100567492","phase-1-comparing-the-pharmacokinetics-of-a-progesterone-ring-versus-a-progesterone-vaginal-insert-100567492","NCT06668896","Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert","An Open-Label, Four-Treatment, Parallel Study of the Comparative Pharmacokinetics of a Progesterone Intravaginal Ring (IVR) 8 mg and 12 mg\u002FDay Versus Progesterone Vaginal Insert 100mg","Inclusion Criteria:\n\n* Individuals assigned female at birth who are post-menopausal, women 40 to 65 years of age, inclusive. Postmenopausal is defined as 6-months of spontaneous amenorrhea with serum FSH levels \\> 40 mIU\u002FmL (if not taking systemic hormone therapy) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.\n* Able and willing to correctly and independently complete all study procedures.\n* Able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.\n* VA vaginal pH of ≤ 5.0. Women with vaginal atrophy may rescreen at least 6 weeks after starting either systemic or topical estradiol therapy.\n* Women who are taking systemic (e.g. oral, injectable, transdermal) progesterone (P4) therapy must have at least 2 weeks of wash out from the last dose prior to visit 2.\n\nExclusion Criteria:\n\n* Subjects with clinically significant chronic kidney disease defined as Glomerular Filtration Rate of \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Subjects with uninvestigated hematuria\n* Subjects with known nephrolithiasis, known polycystic kidney disease (PKD), or other known renal genetic disorders\n* Subjects with prior pelvic malignancies requiring radiation therapy, or whose surgery for such has led to complications such as fistulas, etc.\n* Subjects with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following:\n\n  * Active chronic hepatitis B or hepatitis C infection including hepatitis B surface antigen and hepatitis C antigen positive patients with or without abnormal liver enzymes\n  * Concurrent neurodegenerative disease\n  * Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 6 months or serious uncontrolled cardiac arrhythmia or use of Class 1 antiarrhythmic\n  * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol\n* Subjects with hypersensitivity toward any ingredients in the study treatments.\n* Participation in any other investigational drug or device trial in which administration of an investigational study drug\u002Fdevice occurred within 30 days or placement of a non-drug eluting medical device within 15 days prior to the Screening Visit (Visit 1). This does not include re-enrollments into this study, who require at least 14 days of washout prior to re-enrollment.",true,"40 Years","65 Years",{"count":56,"type":21},60,[58],"PHASE1","This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of these vaginal rings over an extended period of time.",[61],"Pre Term Birth",[63],"normal healthy","2026-05-07",{"date":66,"type":36},"2026-05-08",{"date":68,"type":21},"2026-09",{"date":70,"type":21},"2028-04",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":52,"sex":16,"minAge":79,"maxAge":53,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100525858","contraceptive-efficacy-study-of-ovaprene-100525858","NCT06127199","Contraceptive Efficacy Study of Ovaprene","A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene","Inclusion Criteria:\n\n* Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception.\n* General good health, by subject history and per investigator judgement\n* Age 18 through 40 years, inclusive; approximately 66 subjects \\>35 years old at visit 2 will be the Enrolled-Eligible Population\n* In a relationship with a person assigned male at birth who meets eligibility criteria below.\n\n  --At least 18 years old, not known to be subfertile or infertile\n* Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heave bleeding that lasts longer than 5 days\n* Be willing to stop their current method of contraception (with the exception of condoms) before Visit 2. Participants must experience at least one subsequent menstrual bleed before inserting Ovaprene. Participants using injectable contraception must be at least 9 months post their last dose at screening and have experienced at least 2 subsequent regular menstrual bleeds that were part of cycles of 21-35 days. After stopping their current method of contraception, subjects must either abstain fro vaginal sex or use condoms before inserting their first Ovaprene\n* Not be actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy\n* Expect to engage in at least 4 acts of heterosexual vaginal intercourse per cycle during the study.\n* Be willing to only use Ovaprene as the sole method of contraception over the course of the study\n* Agree not to participate in any other clinical trials during the course of the study\n* Be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits\n* Microbiota\u002Finnate immunity and colposcopy subsets only:\n\n  * Be willing to avoid vaginal sex and using tampons and other intravaginal products for 48 hours prior to clinic visits; and be willing to comply with subset procedures\n\nExclusion Criteria:\n\n* Currently pregnant and\u002For have a positive urine pregnancy test at screening.\n* Have an allergy to the ingredients in Ovaprene\n* Have a history of toxic shock syndrome\n* Have a history of hereditary hemochromatosis\n* Be breastfeeding an infant\n* Have a history suggestive of infertility, defined as any of the following: known history of ectopic pregnancy or other fertility problem; sterilization\u002Fpermanent contraception; endometriosis or hospitalization for pelvic inflammatory disease (PID) unless subject has had a subsequent spontaneous intrauterine pregnancy; or use of medications that could cause subfertility such as gonadotropin-releasing hormone agonists\n* Currently have postcoital bleeding\n* Have contraindications to pregnancy (medical condition) or chronic use of medications contraindicated in pregnancy\n* Have a history of clinically significant uterine prolapse, cystocele, or rectocele that has required surgical intervention or pessary use\n* Positive human immunodeficiency virus (HIV) test at screening\n* Have exclusionary results on human papilloma virus (HPV) screening\u002Fcytology (subjects\\>\u002F=21 years old) at screening or require treatment or follow-up for an abnormal Pap smear or HPV test that would be needed during the study.\n* Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3 months prior to screening\n* Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance\n* Have previously been included in the Enrolled-Eligible Population\n* Is a direct employee or immediate family member of the Sponsor company, site Investigators or study staff\n* Have taken any investigational drug or used any investigational device within the 30 days prior to screening\n* Have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results\n* Microbiota\u002Finnate immunity subset only:\n\n  --systemic use in the last 2 weeks prior to screening or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), candidiasis, or bacterial vaginosis(BV) diagnosed at Visit 1) or antivirals;\n* If male partner has or is suspected to have had an HIV infection or other sexually transmitted infection\n* if male partner has a known sensitivity or allergy to the ingredients in Ovaprene\n* If male partner has previously participated in this study or has taken any investigational drug or used any investigational device within 30 days prior to the female subject's screening\n* If the male partner has a history of any severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or could interfere with the interpretation of trial results.","18 Years",{"count":81,"type":21},656,[83],"NA","This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene.",[86],"Contraception",[88,89],"Device","Non-hormonal","RECRUITING",{"date":92,"type":36},"2026-05-11",{"date":94,"type":36},"2023-12-19",{"date":96,"type":21},"2027-09",{"name":42,"class":43},27,""]