Drugs / Clotrimazole
Clotrimazole
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LOTRIMIN | — | 1989-10-27 – 2007-12-07 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | GYNE-LOTRIMIN | — | 1990-11-30 – 1993-04-26 | fda.gov ↗ |
| Label expansion | US (FDA) | MYCELEX | — | 1992-09-29 | fda.gov ↗ |
| Label expansion | US (FDA) | MYCELEX-7 | — | 1991-12-26 | fda.gov ↗ |
| Approved | US (FDA) | LOTRIMIN | — | 1975-02-03 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06339294 | Jun → Dec 2023 | otomycosis | Rawalpindi Medical College | Completed | No outcome recorded |
| Phase 1 | NCT01524432 | Jan → May 2012 | tinea pedis | Prof. Yuen Chun-Wah | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07331792 | Feb → May 2026 overdue | pityriasis versicolor | Combined Military Hospital Abbottabad | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03024502 | Jan 2018 → Jan 2020 | vulvovaginal candidiasis | University of Sao Paulo | Unknown | No outcome recorded |
| Phase 1/2 | NCT00004492 | Oct 1999 → Sep 2001 | sickle cell disease | University of North Carolina | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06835361 | Feb 2024 → Sep 2025 overdue | vulvovaginal candidiasis | AVVA Pharmaceuticals Ltd. | Recruiting | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT03686397 | Jun 2020 → Oct 2021 | otomycosis | Salvat | Completed | No outcome recorded |
| Phase 3 | NCT03686384 | Feb 2020 → Oct 2021 | otomycosis | Salvat | Completed | No outcome recorded |
| Phase 3 | NCT02582177 | Jun 2019 → Jan 2020 | tinea infection | Ache Laboratorios Farmaceuticos S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02635438 | Dec 2016 → Sep 2018 | candidiasis | Thinq Pharma-CRO Pte. Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02713139 | Sep 2013 → Mar 2014 | vaginal discharge | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01105013 | Apr → Jul 2012 | dermatophytosis of groin and perianal area, tinea corporis, tinea pedis | Laboratório Teuto Brasileiro S/A | Unknown | No outcome recorded |
| Phase 3 | NCT00755053 | Sep 2008 → May 2009 | vulvovaginal candidiasis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00313131 | Jan 2004 → May 2005 | bacterial vaginosis, candidiasis | University of Sherbrooke | Completed | No outcome recorded |
| Phase 3 | NCT02184351 | May → Nov 2001 | oral candidiasis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00000676 | ? → Nov 1993 | HIV infectious disease, candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT06869681 | Mar → May 2025 overdue | tinea pedis | Jinnah Postgraduate Medical Centre | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06349122 | Aug 2024 → Mar 2027 expected | bacterial vaginosis | Assistance Publique Hopitaux De Marseille | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02180828 | Jul 2014 → Sep 2015 | vulvovaginal candidiasis | Peking University Shenzhen Hospital | Completed | Met primary |
| Phase 4 | NCT00671528 | Jul 2009 → May 2010 | atopic eczema | Organon and Co | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable5 trials | ||||||
| — | NCT07535424 | Nov 2024 → Oct 2025 | otomycosis | Mayo Hospital Lahore | Completed | No outcome recorded |
| — | NCT04292704 | Dec 2019 → Mar 2022 | vulvovaginal candidiasis | Second Affiliated Hospital of Wenzhou Medical University | Unknown | No outcome recorded |
| — | NCT01547221 | Mar 2012 → Apr 2015 | otomycosis | Khon Kaen Hospital | Completed | No outcome recorded |
| — | NCT00004404 | Apr 1997 → Sep 2002 | sickle cell disease | Boston Children's Hospital | Completed | No outcome recorded |
| — | NCT00002282 | — | HIV infectious disease, oral candidiasis | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT07441005 Comparator | May → Oct 2025 | dermatophytosis of groin and perianal area | Hayat Abad Medical Complex, Peshawar | Completed | No outcome recorded |
| Phase 1 | NCT02847286 Comparator | Sep 2015 → Nov 2016 | — | International Partnership for Microbicides, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00078559 Background | Nov 2003 → Feb 2010 | kidney disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1/2 | NCT00061282 Comparator | Sep 2002 → Dec 2020 | pouchitis, ulcerative colitis | Web | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03632733 Comparator | Jan → Oct 2018 | — | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT00835029 Comparator | Mar 2009 → Feb 2012 | denture stomatitis, oral candidiasis | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 2/3 | NCT03005353 Comparator | Mar 2018 → Oct 2019 | fungal infectious disease | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT03115073 Comparator | Apr 2017 → Jul 2018 | vulvovaginal candidiasis | ProFem GmbH | Completed | No outcome recorded |
| Phase 2/3 | NCT01244256 Background | Apr → Aug 2007 | folliculitis | Azidus Brasil | Suspended | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02907307 Comparator | Dec 2018 → Dec 2019 | vulvovaginal candidiasis | Medinova AG | Withdrawn | No outcome recorded |
| Phase 3 | NCT01993823 Comparator | May 2013 → Nov 2014 | otomycosis | Salvat | Completed | No outcome recorded |
| Phase 3 | NCT00390780 Comparator | Jul 2006 → Dec 2007 | HIV infectious disease | Valerio Therapeutics | Completed | Missed primary |
| Phase 4 | NCT04699240 Comparator | Jul 2020 → Dec 2023 | vulvovaginal candidiasis | Peking University Shenzhen Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02860845 Comparator | Jul 2016 → Oct 2017 | bacterial vaginosis, candidiasis | Laboratorios Ordesa | Completed | No outcome recorded |
| Phase 4 | NCT02242695 Comparator | Nov 2014 → Dec 2015 | vulvovaginal candidiasis | Medinova AG | Completed | No outcome recorded |
| Phase 4 | NCT01697826 Comparator | Apr → Sep 2011 | infective vaginitis | Dr Bharti Daswani | Completed | No outcome recorded |
| — | NCT07867223 Comparator | Jul 2025 → Nov 2026 expected | otomycosis | Deraya University | Recruiting | No outcome recorded |
| — | NCT01049633 Background | — | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | No longer available | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clotrimazole | “The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole...” NCT02635438 ↗40“Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗ “Clotrimazole 1% ear drops: Aqueous solution of 200 mg clotrimazole in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal as per standard clinical practice for 7 days.” NCT07867223 ↗ “Baycuten N® is a cream composed by clotrimazole 10mg and dexamethasone acetate 0.443 mg/g that will be dispensed to 80 participants of this group in the first stage.” NCT02582177 ↗ “100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis” NCT02242695 ↗ “intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole” NCT01697826 ↗ |
| Known as | BAY-B5097 | “Clotrimazole ovule (Canesten, BAY-B5097)” NCT00755053 ↗ |
| Known as | Canesten | “In the second stage Canesten ® will be dispensed to the same participants. It´s a cream composed by clotrimazole 10mg that will be applied in the affected area once a day for 14 days.” NCT02582177 ↗3“100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis” NCT02242695 ↗ “Clotrimazole ovule (Canesten, BAY-B5097)” NCT00755053 ↗ “Canesten (Clotrimazole)” NCT06835361 ↗ |
| Known as | Clotrimazole, Vaginal | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06349122 ↗ |
| Known as | SVT-15652 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03686397 ↗ |
| Route | Oral | “To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of...” NCT00002282 ↗ |