Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

NCT02180100

Vulvovaginal Candidiasis

COMPLETED PHASE4

A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis

NCT05074602

Recurrent Vulvovaginal Candidiasis

UNKNOWN PHASE3

Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

NCT02242695

Vulvovaginal Candidiasis

COMPLETED PHASE4

A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

NCT04956419

Acute Vulvovaginal Candidiasis

UNKNOWN PHASE3

A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

NCT01176058

Candidemia

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Candidiasis, Vulvovaginal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clotrimazole vaginal tablet

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Group Type EXPERIMENTAL

Clotrimazole vaginal tablet

Intervention Type DRUG

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Fluconazole

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clotrimazole vaginal tablet

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Intervention Type DRUG

Fluconazole

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Canesten Diflucan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
2. Subject completes the informed consent process
3. Subject agrees to take study medication when scheduled
4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria

1. had any other sexually transmitted disease or gynaecological abnormality requiring treatment
2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
3. were pregnant
4. had used antifungal medication in the week before entry
5. were expected to menstruate within seven days of the start of treatment
6. infected more than one candida species

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No