Biomaterial Database

Comparison of single administration with an ovule of 600 mg fenticonazole versus a 500 mg clotrimazole vaginal pessary in the treatment of vaginal candidiasis. 1989

W Wiest, and E Azzollini, and R Ruffmann

Gynaecology Department, Vinzenz Hospital, Mainz, FRG.

Fenticonazole is an imidazole derivative with a broad spectrum of antimycotic activity. The therapeutic activity and tolerability of 600 mg fenticonazole versus 500 mg clotrimazole were evaluated in an investigator-blind trial in 80 patients with mycologically confirmed vaginal candidiasis. Fenticonazole was administered as an ovule and clotrimazole as a vaginal pessary, both in a single administration. Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days after the start of treatment. Patients cured at the end of the trial were rechecked 4-5 weeks after the start of therapy in order to identify and evaluate possible relapse. Both treatments resulted in a statistically significant reduction in vaginal symptoms (erythema, itching, discharge and oedema) and in elimination of Candida albicans in about 90% of patients. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis was indicated.

UI	MeSH Term	Description	Entries
D007093	Imidazoles	Compounds containing 1,3-diazole, a five membered aromatic ring containing two nitrogen atoms separated by one of the carbons. Chemically reduced ones include IMIDAZOLINES and IMIDAZOLIDINES. Distinguish from 1,2-diazole (PYRAZOLES).
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D012008	Recurrence	The return of a sign, symptom, or disease after a remission.	Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D002181	Candidiasis, Vulvovaginal	Infection of the VULVA and VAGINA with a fungus of the genus CANDIDA.	Moniliasis, Vulvovaginal,Vaginitis, Monilial,Candidiasis, Genital,Genital Vulvovaginal Candidiasis,Vaginal Yeast Infection,Vaginal Yeast Infections,Candidiasis, Genital Vulvovaginal,Genital Candidiasis,Infection, Vaginal Yeast,Infections, Vaginal Yeast,Monilial Vaginitis,Vulvovaginal Candidiasis,Vulvovaginal Candidiasis, Genital,Vulvovaginal Moniliasis,Yeast Infection, Vaginal,Yeast Infections, Vaginal
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003022	Clotrimazole	An imidazole derivative with a broad spectrum of antimycotic activity. It inhibits biosynthesis of the sterol ergostol, an important component of fungal CELL MEMBRANES. Its action leads to increased membrane permeability and apparent disruption of enzyme systems bound to the membrane.	Bay b 5097,Canesten,FB b 5097,Kanesten,Klotrimazole,Lotrimin,Mycelex
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000282	Administration, Intravaginal	The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories.	Administration, Vaginal,Drug Administration, Vaginal,Instillation, Vaginal,Intravaginal Administration,Vaginal Drug Administration,Vaginal Administration,Administration, Vaginal Drug,Administrations, Intravaginal,Administrations, Vaginal,Administrations, Vaginal Drug,Drug Administrations, Vaginal,Instillations, Vaginal,Intravaginal Administrations,Vaginal Administrations,Vaginal Drug Administrations,Vaginal Instillation,Vaginal Instillations