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NCT Number: NCT02180828

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

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

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Key information

Conditions

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

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Subject completes the informed consent process
  • Subject agrees to take study medication when scheduled
  • Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion criteria

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

Treatment and study plan

Clotrimazole vaginal tablet

Drug

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

Other names: Canesten

Fluconazole

Drug

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

Other names: Diflucan

Primary outcomes

  1. Therapeutic Efficacy 1

    Time frame: 7-14 days after treatment (=visit 2)

    The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.

  2. Therapeutic Efficacy 2

    Time frame: at days 30-35 follow-up

    The clinical cure rates of clotrimazole and fluconazol

  3. Therapeutic Efficacy 3

    Time frame: at days 7-14 follow-up

    Mycological cure of clotrimazole group and fluconazole group

  4. Therapeutic Efficacy 4

    Time frame: at days30-35 follow-up

    Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.

Secondary outcomes

  1. Adverse Events 1

    Time frame: at day 7-14 follow up

    Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.

  2. Adverse Events 2

    Time frame: at day 7-14 follow up

    Vulvovaginal pruritus, burning, irritation, and bleeding

  3. Adverse Events 3

    Time frame: at day 7-14 follow up

    Gastrointestinal tract: abdominal pain, diarrhoea, nausea

  4. Adverse Events 4

    Time frame: at day 7-14 follow up

    Skin sensitivity, urticaria rash, erythematous rash, irritation

  5. Total Adverse Events

    Time frame: at day 7-14 follow up

    Total adverse events(cases)

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Collaborators

  • Bayer

Registry information

Official study title

An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2014
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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