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Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03473418
Recruitment Status : Unknown
Verified March 2018 by Mariana Noss Abdo, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Mariana Noss Abdo, Assiut University

Brief Summary:
Vaginal Candidiasis is an infection caused by a yeast normally lives inside the body . Sometimes Candida can multiply and cause an infection if the environment inside the vagina changes in a way that encourages its growth. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Risk factor use of intra uterine devices , pregnancy ,use hormonal contraceptives ,have diabetes , immune compromised taken antibiotics Diagnosis cause itching or soreness Pain during sexual intercourse Pain or discomfort when urinating and abnormal vaginal discharge Although most vaginal candidiasis is mild, some women can develop severe infections involving redness, swelling, and cracks in the wall of the vagina

Condition or disease Intervention/treatment Phase
Vaginal Candidiasis Drug: Ketoconazole Drug: Terconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketoconazole In Situ Gel Versus Terconazole Cream for Treatment of Vaginal Candidiasis
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Ketoconazole gel
use of Ketoconazole in situ gel for treatment of vaginal candidiasis
Drug: Ketoconazole
Ketoconazole as a topical vaginal gel

Active Comparator: terconazole cream
use of terconazole 0.8 cream for treatment of vaginal candidiasis
Drug: Terconazole
Terconazole 80 mg as a topical vaginal cream

Primary Outcome Measures :
  1. measure effect of ketoconazole gel in treatment of vaginal candidiasis [ Time Frame: ketoconazole used once daily for 3 days ]
    efficacy of ketoconazole gel by taking a vaginal swab for microbiological examination before treatment and another swab one week after treatment

  2. improvement of patient complaint [ Time Frame: one week ]
    improvement of vaginal symptoms and discharge

Secondary Outcome Measures :
  1. rate of relapse [ Time Frame: 2 weeks ]
    recurrence of symptoms and discharge (patient complaint )

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The selected patients had - vaginal candidiasis ,diagnosed by history of pruritus in addition to the characteristic discharge of vaginal candidiasis by vaginal examination

Exclusion Criteria:

  • Women on other line of treatment as antimicrobial treatment either topical or systemic drugs within one month prior to the first clinical examination
  • Known hypersensitivity for ketoconazole
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Responsible Party: Mariana Noss Abdo, Egypt Assiut ( Elghnium city), Assiut University
ClinicalTrials.gov Identifier: NCT03473418    
Other Study ID Numbers: KTVC
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis, Vulvovaginal
Bacterial Infections and Mycoses
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Vulvar Diseases
Genital Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors