[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoactive-sexual-desire-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoactive-sexual-desire-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100641190","phase-1-bre-06-study-to-increase-tolerance-to-aromatase-inhibitors-for-patients-with-early-stage-hormone-receptor-positive-breast-cancer-who-developed-hypoactive-sexual-desire-disorder-100641190",false,"NCT07596212","BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder","Inclusion Criteria:\n\n* Females 18 or older\n* Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and\u002For progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status\n* Completion of the following planned cancer treatments prior to registration:\n\n  * Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)\n  * Adjuvant radiation therapy, if needed\n  * Neoadjuvant and\u002For adjuvant chemotherapy if needed\n  * Treatment with anti-HER2 agents is allowed\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n* Ability to swallow oral medication.\n* Provide written informed consent and fill out questionnaires\n* Willing to return to the enrolling institution for follow-up\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. Women of childbearing potential will be required to use effective contraception from the time of consent until 30 days after the last dose of bupropion. Acceptable methods include hormonal contraception, intrauterine device, barrier methods with spermicide, or sterilization\n\nExclusion Criteria:\n\n* Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.\n* History of psychiatric illnesses on active treatment\n* History or active suicidal thoughts or behaviors\n* Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder\n* History of bulimia or anorexia nervosa\n* Inhibitors or inducers of CYP2B6\n* Drugs metabolized by CYP2D6\n* Use of monoamine oxidase inhibitors (MAOI)\n* History of hypertension, regardless of control status.\n* History of angle closure glaucoma\n* Subjects taking levodopa, amantadine, methylene blue, and linezolid\n* Those with a hypersensitivity to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide. Currently receiving any of the following cancer-directed therapies:\n\n  * Radiation therapy\n  * Systemic therapy such as chemotherapy (standard or investigational)\n  * Anti-HER2 agents are allowed","FEMALE","18 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.",[26,27,28,29],"Early-stage Breast Cancer","Hypoactive Sexual Desire Disorder","Hormone Receptor Positive Breast Carcinoma","Breast Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":19},"2026-07",{"date":38,"type":19},"2031-07",{"name":40,"class":41},"University of Illinois at Chicago","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100522453","phase-2-an-open-label-study-of-50-mg-oral-testosterone-undecanoate-kyztrex-in-menopausal-women-with-low-testosterone-and-hsdd-100522453","NCT06082817","An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD","An Open-Label Pilot Study of the Pharmacokinetics and Safety of 50 Mg Oral Testosterone Undecanoate (Kyzatrex) in Menopausal Women with Low Testosterone and Hypoactive Sexual Desire Disorder","Inclusion Criteria:\n\n1. Participant provides written informed consent and HIPAA authorization before any study procedures are conducted;\n2. Participant is female;\n3. Participant is aged 30 years or greater;\n4. Participant is menopausal either spontaneously (at least 12 months amenorrheic or 6 months amenorrheic and FSH \\>40 IU\u002Fml) or 6 weeks after bilateral salpingo-oophorectomy with or without hysterectomy.\n5. Participant has a body mass index (BMI) ≤ 34 kg\u002Fm2;\n6. Participant has a diagnosis of hypoactive sexual desire disorder;\n7. At screening, participant has a testosterone concentration \\\u003C30 ng\u002FdL;\n8. Participant has a normal PAP smear within 6 months of first administration of study drug if participant has a cervix;\n9. Participant has a normal mammogram within 6 months of first administration of study drug;\n10. Participant agrees to comply with the study procedures and visits.\n\nExclusion Criteria:\n\n1. Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or titanium dioxide (the constituents of Kyzatrex capsule);\n2. Participant has received intramuscular testosterone injections, oral or transdermal testosterone within 4 weeks, or subcutaneous testosterone pellet within 6 months prior to the screening visit, or receives any form of testosterone other than study drug during this trial;\n3. Participant has documented or suspected breast cancer, history of heart attack or stroke;\n4. Participant has a clinically significant history of disease which could alter absorption, distribution, metabolism, or elimination, such as hepatic, renal, hematologic, gastrointestinal, respiratory, endocrine, or neurological disease;\n5. Participant has an EKG with an abnormality of clinical significance;\n6. Participant has an abnormal PAP smear if she has a cervix;\n7. Participant has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;\n8. Participant requires major surgery within 4 weeks before signing consent or at any time during the study;\n9. Participant requires a treatment with any medication listed in Appendix 1 at any time between 30 days before study drug is started or any time until the end of the study;\n10. Participant has a history of substance abuse within 12 months prior to signing consent;\n11. Participant has received an investigational drug within 30 days prior to signing consent;\n12. Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the participant is unlikely to be compliant with study procedures and visits.",true,"21 Years","75 Years",{"count":54,"type":19},30,[23],"This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 14 days after the last dose of study drug, participants will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).",[27],"2024-11-11",{"date":60,"type":34},"2024-11-13",{"date":62,"type":19},"2025-01-01",{"date":64,"type":19},"2025-12-31",{"name":66,"class":41},"San Diego Sexual Medicine"]