Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

NCT03473418 | Unknown Phase 3

• 1 other identifier: KTVC
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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

Conditions

Vaginal Candidiasis

Outcome Measures

Primary Outcomes (2)

• measure effect of ketoconazole gel in treatment of vaginal candidiasis

  efficacy of ketoconazole gel by taking a vaginal swab for microbiological examination before treatment and another swab one week after treatment

  ketoconazole used once daily for 3 days

• improvement of patient complaint

  improvement of vaginal symptoms and discharge

  one week

Secondary Outcomes (1)

• rate of relapse

  2 weeks

Study Arms (2)

Ketoconazole gel

EXPERIMENTAL

use of Ketoconazole in situ gel for treatment of vaginal candidiasis

Drug: Ketoconazole

terconazole cream

ACTIVE COMPARATOR

use of terconazole 0.8 cream for treatment of vaginal candidiasis

Drug: Terconazole

Interventions

Ketoconazole DRUG

Ketoconazole as a topical vaginal gel

Ketoconazole gel

Terconazole DRUG

Terconazole 80 mg as a topical vaginal cream

terconazole cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Garcia Figueroa RG, Sauceda L, Ramirez Palacios D, Cruz Talonia F, Romero Cabello R. [Effectiveness and safety of ciclopirox olamine 1% vaginal cream versus terconazole 0.8% vaginal cream in the treatment of genital candidiasis]. Ginecol Obstet Mex. 2000 Apr;68:154-9. Spanish.

  PMID: 10824446 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Ketoconazole; terconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Egypt Assiut ( Elghnium city)

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 22, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: March 22, 2018

Record last verified: 2018-03