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Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Information source: Peking University Shenzhen Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis, Vulvovaginal

Intervention: Clotrimazole vaginal tablet (Drug); Fluconazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Peking University Shenzhen Hospital

Official(s) and/or principal investigator(s):
Shangrong Fan, M.D., Principal Investigator, Affiliation: Peking University Shenzhen Hospital

Overall contact:
Y.H. Liang, M.D., Phone: 86-13603025114

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Subjects with mycological and clinical cure

Secondary outcome: vaginal microecology

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Y.H. Liang, M.D., Phone: 86-13603025114

Peking University Shenzhen Hospital, Shenzhen, Guangdong 518036, China; Recruiting
Shangrong Fan, M.D., Phone: 96-0755-83923333, Ext: 5502, Email: fanshangrong@163.com
Additional Information

Starting date: July 2014
Last updated: April 27, 2015

Page last updated: August 23, 2015

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