Drug & intervention

ketoconazole

RxCUI 6135

Clinical trials31
Recruiting0
Related conditions20
Synonyms1

RxNorm ingredient and formulation relationships

Source-verified product relationships. Every strength, delivery form and RxCUI remains a separate clinical concept.

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Background context

Ketoconazole

Ketoconazole, sold under the brand name Nizoral, among others, is an antiandrogen, antifungal, and antiglucocorticoid medication used to treat a number of fungal infections. Applied to the skin it is used for fungal skin infections such as tinea, cutaneous candidiasis, pityriasis versicolor, dandruff, and seborrheic dermatitis. Taken by mouth it is a less preferred option and recommended for only severe infections when other agents cannot be used. Other uses include treatment of excessive male-patterned hair growth in women and Cushing's syndrome. Common side effects when applied to the skin include redness. Common side effects when taken by mouth include nausea, headache, and liver problems. Liver problems may result in death or the need for a liver transplantation. Other severe side effects when taken orally include QT prolongation, adrenocortical insufficiency, and anaphylaxis. It is an imidazole and works by hindering the production of ergosterol required for the fungal cell membrane, thereby slowing growth. Ketoconazole was patented in 1977 by Belgian pharmaceutical company Janssen, and came into medical use in 1981. It is available as a generic medication and formulations that are applied to the skin are over the counter in the United Kingdom. In 2023, it was the 140th most commonly prescribed medication in the United States, with more than 3 million prescriptions. The formulation that is taken by mouth was withdrawn in the European Union and in Australia in 2013, and in China in 2015. In addition, its use was restricted in the United States and Canada in 2013.

Background only. Canonical identity remains RxNorm; clinical-trial relationships come from ClinicalTrials.gov.

Clinical trials

31 shown
Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain MetastasesNCT03796273 · 2019-03-13
TERMINATED
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate CancerNCT02560051 · 2015-11-01
TERMINATED
Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate CancerNCT02494713 · 2015-10-01
TERMINATED
GSK239512 DDI StudyNCT01802931 · 2013-01-07
COMPLETED
Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.NCT01735240 · 2012-12-01
COMPLETED
Effect of Ketoconazole on BreathlessnessNCT01378520 · 2011-06-01
COMPLETED
A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and KetoconazoleNCT01165125 · 2010-07-01
COMPLETED
Ketoconazole and Dexamethasone in Prostate CancerNCT01036594 · 2009-12-11
COMPLETED
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate CancerNCT00953576 · 2009-09-29
TERMINATED
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate CancerNCT00859781 · 2009-06-01
ACTIVE_NOT_RECRUITING
Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior ChemotherapyNCT00895310 · 2009-05-01
COMPLETED
Drug-Drug Interaction (DDI) w/Ketoconazole or FluconazoleNCT00860275 · 2009-04-01
COMPLETED
Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation TherapyNCT00559481 · 2007-10-01
WITHDRAWN
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy VolunteersNCT00501397 · 2007-02-01
COMPLETED
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812NCT00411866 · 2006-10-13
COMPLETED
Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate CancerNCT00536991 · 2006-10-01
TERMINATED
Treating Patients With Prostate Cancer That Did Not Respond to Hormone TherapyNCT00460031 · 2006-09-01
COMPLETED
Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate CancerNCT00447473 · 2006-07-01
TERMINATED
Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot StudyNCT00870714 · 2004-09-01
UNKNOWN
Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone TherapyNCT00309894 · 2004-04-01
COMPLETED
Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate CancerNCT00027859 · 2003-10-08
COMPLETED
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate CancerNCT00030654 · 2002-10-01
COMPLETED
Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate CancerNCT00024167 · 2002-04-01
TERMINATED
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's CycleNCT00586898 · 2001-07-01
COMPLETED
Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate CancerNCT00014352 · 2000-09-01
COMPLETED
A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate CancerNCT00006371 · 2000-05-01
TERMINATED
Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate CancerNCT00019695 · 1999-03-01
TERMINATED
Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate CancerNCT00003084 · 1997-12-01
COMPLETED
Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate CancerNCT00002760 · 1996-08-01
COMPLETED
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate CancerNCT00002855 · 1996-08-01
COMPLETED
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune SystemsNCT00002304
COMPLETED

Leading sponsors

Drug identity and terminology: RxNorm. Trial relationships: ClinicalTrials.gov.