Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Candidiasis, Vulvovaginal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180828
• Other study ID #: pkuszh-2014-02
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2014
• Last updated: April 28, 2017
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: Peking University Shenzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

Drug:
• Clotrimazole vaginal tablet
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
• Fluconazole
2 doses of 150 mg oral Fluconazole (at day1 and day4)

Locations

Country	Name	City	State
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital	Bayer

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Therapeutic Efficacy 2	The clinical cure rates of clotrimazole and fluconazol	at days 30-35 follow-up
Primary	Therapeutic Efficacy 3	Mycological cure of clotrimazole group and fluconazole group	at days 7-14 follow-up
Primary	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	Adverse Events 1	Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.	at day 7-14 follow up
Secondary	Adverse Events 2	Vulvovaginal pruritus, burning, irritation, and bleeding	at day 7-14 follow up
Secondary	Adverse Events 3	Gastrointestinal tract: abdominal pain, diarrhoea, nausea	at day 7-14 follow up
Secondary	Adverse Events 4	Skin sensitivity, urticaria rash, erythematous rash, irritation	at day 7-14 follow up
Secondary	Total Adverse Events	Total adverse events(cases)	at day 7-14 follow up

External Links

•   The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis