Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

NCT02180828 | Completed Phase 4 Results

• 1 other identifier: pkuszh-2014-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Candidiasis, Vulvovaginal

Outcome Measures

Primary Outcomes (4)

• Therapeutic Efficacy 1

  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.

  7-14 days after treatment (=visit 2)

• Therapeutic Efficacy 2

  The clinical cure rates of clotrimazole and fluconazol

  at days 30-35 follow-up

• Therapeutic Efficacy 3

  Mycological cure of clotrimazole group and fluconazole group

  at days 7-14 follow-up

• Therapeutic Efficacy 4

  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.

  at days30-35 follow-up

Secondary Outcomes (5)

• Adverse Events 1

  at day 7-14 follow up

• Adverse Events 2

  at day 7-14 follow up

• Adverse Events 3

  at day 7-14 follow up

• Adverse Events 4

  at day 7-14 follow up

• Total Adverse Events

  at day 7-14 follow up

Study Arms (2)

Clotrimazole vaginal tablet

EXPERIMENTAL

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

Drug: Clotrimazole vaginal tablet

Fluconazole

ACTIVE COMPARATOR

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

Drug: Fluconazole

Interventions

Clotrimazole vaginal tablet DRUG

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

Also known as: Canesten

Clotrimazole vaginal tablet

Fluconazole DRUG

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

Also known as: Diflucan

Fluconazole

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead
• Bayer: collaborator

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Related Publications (1)

• Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.

  PMID: 27073145 RESULT

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole; Fluconazole

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)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles

Results Point of Contact

• Title: Shangrong Fan
• Organization: Peking University

fanshangrong@163.com

860755-83923333

Study Officials

• Shangrong Fan, M.D.

  Peking University Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Dept of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 3, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 2, 2017
• Results First Posted: September 30, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)