[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biozeus Biopharmaceutical S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,76],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100566158","phase-2-evaluation-of-the-efficacy-in-increasing-sexual-arousal-safety-and-tolerability-of-bz371a-in-women-with-sexual-arousal-disorder-100566158",false,"NCT06651541","Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder","Phase 2 Parallel Clinical Study to Evaluate the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Gel Form Applied to Women With Sexual Arousal Disorder","Inclusion Criteria:\n\n* Women aged between 21 and 65 years;\n* Premenopausal or postmenopausal women may be included;\n* May or may not be using female sex hormones (estrogen with or without progesterone, or their derivatives);\n* Women who have previously had sexual experiences with orgasm, desire, and arousal, for a minimum period of two years;\n* FSD, defined according to DSM-IV diagnostic criteria, that is, the presence of a persistent or recurrent inability to achieve or maintain adequate physiological sexual arousal during sexual activity, meaning a reduction or absence of genital response (lubrication, clitoral swelling, or other genital responses such as genital pleasure sensations);\n* FSD causes significant personal distress and\u002For interpersonal difficulty;\n* FSFI questionnaire meeting criteria for female sexual dysfunction, i.e., \\\u003C26.5;\n* Stable relationship for more than 6 months, with a sexually active partner who is present (cannot be traveling, for example) during the treatment period;\n* Ability to read and understand the Informed Consent Form (ICF) and to complete the questionnaires.\n\nExclusion Criteria:\n\n* Women who do not agree to use a contraceptive method and who have the capacity to become pregnant during the study;\n* Women who do not agree to attempt sexual activity at least twice a week while taking the study medication;\n* Serious relationship problems, defined as a CSI-16 score below 51.5, of non-sexual origin, and which, in the investigator's opinion, may influence sexual activities;\n* History of unresolved sexual trauma or abuse, that could interfere with participation or the results of the study;\n* Diagnosis of vaginismus, genitopelvic pain\u002Fpenetration disorder and\u002For sexual aversion disorder;\n* Uncontrolled diabetes at screening visit (HbA1C \\> 10%);\n* Prior spinal cord injury, with lower limb paralysis;\n* History of abdominal or pelvic surgery that may have damaged pelvic nerves, including vulvectomy, colostomy, cytostomy, hysterectomy, or bladder suspension;\n* Current testosterone use, or long-term testosterone use (such as chip) within the past 6 months;\n* Patients with severe current depression, characterized by the use or need for the use of psychotropic medications, including bupropion, lithium, or neuroleptics (patients using antidepressant medications such as selective serotonin reuptake inhibitors may participate);\n* Presence of genital lesions that impair analysis of local adverse effects on the genitalia;\n* Presence of diseases that cause excessive vaginal discharge, such as recurrent urinary tract infection, vaginal infection and pelvic inflammatory disease.\n* Abnormal Papanicolaou test within the past 3 years;\n* History of gynecological cancer (history of uterine dysplasia can be included, provided it has been properly treated for at least 6 months);\n* History of pelvic irradiation;\n* Use of topical medications in the genital region that may interfere with PSI assessment as well as their absorption or drug interaction, including vaginal estrogens, lubricants, spermicides, creams or gels, vaginal douches;\n* History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart disease (including history of angina and\u002For heart failure) and nephropathies;\n* Current use of nitrates, such as propatylnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®)\n* ECG findings that are clinically symptomatic, or that, in the Investigator's judgment, are considered significant and pose a risk to the research volunteer's participation;\n* Findings on laboratory tests that, in the Investigator's judgment, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;\n* TSH outside the normal range for age and\u002For participants with hypothyroidism who started thyroid hormone replacement less than 3 months ago, even if TSH is within normal limits;\n* BP outside safe limits: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except for situations such as \"white coat\" syndrome;\n* Severe hypertension, considered to be the use of three or more antihypertensive drugs;\n* Diseases that can cause clitoral priapism, such as sickle cell anemia, multiple myeloma or leukemia;\n* History of clitoral priapism;\n* Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or malabsorptive syndrome, or presence of mucus, pus, or blood in the stool;\n* Pregnant or lactating;\n* Current use of nitric oxide donors, guanylate cyclase stimulators (e.g. Riociguat), or 5- phosphodiesterase inhibitors (Sildenafil, Tadalafil, etc.);\n* Any disease or condition or physical finding that the Investigator considers significant and that increases the risk of the research participant's participation or may interfere with the results, including serious debilitating diseases, presence of cancer, serious mental illness, persistent abuse of medication;\n* Partners with significant erectile dysfunction, defined as the inability to maintain an erection to provide satisfactory sexual intercourse in most sexual encounters;\n* Having participated in the BZ371CLI601 study;\n* Known hypersensitivity to BZ371A or any of the components of the formulation;\n* Significant tobacco or alcohol abuse that, in the investigator's opinion, may impair the participant's sexual function (light or moderate use of tobacco or alcohol is permitted);\n* Less than 3 valid sexual encounters, defined as a \"yes\" answer to question 7 of the FSEP, or use of less than 3 doses of PSI in the run-in period.","FEMALE","21 Years","65 Years",{"count":20,"type":21},174,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Evaluation of the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder",[27,28],"Female Sexual Arousal Disorder","Female Sexual Dysfunction (FSD)",[30,31,32],"sexual dysfunction","Topical application","female","NOT_YET_RECRUITING","2025-11-14",{"date":36,"type":37},"2025-11-17","ACTUAL",{"date":39,"type":21},"2026-07-01",{"date":41,"type":21},"2027-07-31",{"name":43,"class":44},"Biozeus Biopharmaceutical S.A.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":45},"100525000","phase-2-evaluation-of-the-efficacy-safety-and-tolerability-of-bz371a-in-women-with-sexual-arousal-disorder-100525000","NCT06116045","Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder","Phase 2 Clinical Study to Evaluate the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Gel Form Applied to Women with Sexual Arousal Disorder","Inclusion Criteria:\n\n* Women between the ages 21 and 60;\n* Pre-menopausal or post-menopausal women may be included;\n* May or may not be taking female sex hormones (estrogen with or without progesterone, or their derivatives);\n* FSAD, defined as the inability, persistent or recurrent, to obtain or maintain until the conclusion of sexual activity an adequate genital response to sexual arousal (lubrication, warmth and enlargement of the clitoris);\n* Women with FSAD who present marked suffering or interpersonal difficulties;\n* Stable relationship for more than 6 months, with a sexually active partner;\n* Ability to read and understand the Informed Consent Form (ICF) and to answer the questionnaires.\n\nExclusion Criteria:\n\n* Women who do not agree to use a contraceptive method and who have the capacity to become pregnant during the study;\n* Women who do not agree to attempt sexual activity at least twice a week while taking the study medication;\n* History of unresolved sexual trauma or abuse;\n* Diagnosis of vaginismus, genitopelvic pain\u002Fpenetration disorder and\u002For sexual aversion disorder;\n* Uncontrolled diabetes at screening visit (HbA1C \\> 10%);\n* Prior spinal cord injury, with lower limb paralysis;\n* History of abdominal or pelvic surgery that may have damaged pelvic nerves, including vulvectomy, colostomy, cytostomy, hysterectomy, or bladder suspension.\n* Current testosterone use, or long-term testosterone use (such as chip) within the past 6 months;\n* Presence of menstrual irregularity or endocrinopathies that significantly alter the menstrual cycle, preventing Cytocam analyses from taking place at the same time;\n* Patients with current depression, characterized by the use or need for use of psychotropic drugs, including bupropion, lithium, or neuroleptics;\n* Presence of genital lesions that impair analysis of local adverse effects on the genitalia;\n* Presence of diseases that cause excessive vaginal discharge, such as recurrent urinary tract infection, vaginal infection and pelvic inflammatory disease.\n* Abnormal Papanicolaou test within the past 3 years;\n* History of gynecological cancer (history of uterine dysplasia can be included, provided it has been properly treated for at least 6 months);\n* History of pelvic irradiation;\n* Use of topical medications in the genital region that may interfere with PSI assessment as well as their absorption or drug interaction, including vaginal estrogens, lubricants, spermicides, creams or gels, vaginal douches;\n* History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart disease (including history of angina and\u002For heart failure) and nephropathies;\n* Current use of nitrates, such as propatylnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and sosorbitol dinitrate (Isocord®)\n* ECG findings that are clinically symptomatic, or that, in the Investigator's judgment, are considered significant and pose a risk to the research volunteer's participation;\n* Findings on laboratory tests that, in the Investigator's judgment, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;\n* TSH outside normal limits for age (participants with hypothyroidism on stable dose of medication, over 3 months, may be included);\n* BP outside safe limits: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except for situations such as \"white coat\" syndrome\n* Severe hypertension, considered as use of three or more antihypertensives;\n* Diseases that can cause clitoral priapism, such as sickle cell anemia, multiple myeloma or leukemia;\n* History of clitoral priapism;\n* Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or malabsorptive syndrome, or presence of mucus, pus, or blood in the stool;\n* Pregnant or lactating;\n* Current use of nitric oxide donors, guanylate cyclase stimulators (e.g. Riociguat), or 5- phosphodiesterase inhibitors (Sildenafil, Tadalafil, etc.);\n* Any disease or condition or physical finding that the Investigator considers significant and that increases the risk of the research participant's participation or may interfere with the results, including serious debilitating diseases, presence of cancer, serious mental illness, persistent abuse of medication.","60 Years",{"count":55,"type":21},30,[24],"To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.",[27,59],"Female Sexual Dysfunction",[61,62,63,64,65,66],"Female","Sexual arousal disorder","Sexual dysfunction","FSFI questionnaire","Nitric Oxide","Topic","RECRUITING","2024-10-18",{"date":70,"type":37},"2024-10-22",{"date":72,"type":37},"2024-10-01",{"date":74,"type":21},"2025-03-31",{"name":43,"class":44},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100482129","phase-2-safety-and-efficacy-evaluation-of-bz371a-topically-applied-on-prostatectomized-patients-100482129","NCT05558007","Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients","Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy","Inclusion Criteria:\n\n1. Men between the ages of 40 and 65 years;\n2. Exclusive heterosexual men, regardless of race or social class.\n3. RP due to prostate cancer without metastasis;\n4. RP performed less than 60 days before the screening visit;\n5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;\n6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.\n7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.\n\nExclusion Criteria:\n\n1. Prostate cancer in TNM stage classified as T3 or T4.\n2. Perineal and\u002For open RP;\n3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;\n4. Uncontrolled diabetes at screening visit (HbA1C \\> 10%);\n5. Prior spinal cord injury with lower limb paralysis;\n6. Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol\u002FL (2300 pg\u002FmL) or total testosterone between 8 and 11 nmol\u002FL (2300 and 3170 pg\u002FmL) and free testosterone \\\u003C 220 pmol\u002FL (\\\u003C 64 ng\u002FdL);\n7. Patients with current depression, characterized by use or need for use of antidepressants.\n8. Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;\n9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;\n10. Possession of penile prosthesis;\n11. History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and\u002For heart failure) and nephropathies;\n12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.\n13. Findings on ECG and\u002For laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;\n14. BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as \"white coat syndrome\";\n15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;\n16. Histroy of priapism, defined as painful erection from up to 6 hours.\n17. Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;\n18. Known hypersensitivity to tadalafil and\u002For BZ371A;\n19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;\n20. Low adhsesion to 5mg Tadalafil use, characterized by the use of \\\u003C80% of the pills between the 30th and 60th day post PR;.\n21. Pregnant or lacting partner.\n22. Partner in childbearing age which does not accept to get exposed to the treatment\n23. Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;","MALE","40 Years",{"count":86,"type":21},72,[24],"To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.",[90,91,92,93],"Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction","Prostate Cancer","Radical Prostatectomy",[91,93,92],{"date":70,"type":37},{"date":97,"type":37},"2023-11-22",{"date":99,"type":21},"2025-01-31",{"name":43,"class":44},""]