A Multi-center Randomized Single-blind Parallel Active Controlled Clinical Trial to Eevaluate the Efficacy and Safety of Butoconazole Nitrate Vaginal Suppository for Vulvovaginal Candidiasis

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-10001039
• Date of registration: 2010-09-26
• Prospective Registration: No
• Primary sponsor: West China Second University Hospital, Sichuang University
• Public title: A Multi-center Randomized Single-blind Parallel Active Controlled Clinical Trial to Eevaluate the Efficacy and Safety of Butoconazole Nitrate Vaginal Suppository for Vulvovaginal Candidiasis
• Scientific title: A Multi-center Randomized Single-blind Parallel Active Controlled Clinical Trial to Eevaluate the Efficacy and Safety of Butoconazole Nitrate Vaginal Suppository for Vulvovaginal Candidiasis
• Date of first enrolment: 2009-04-24
• Target sample size: 1:120;2:120;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8499
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: II (Phase II study)

Countries of recruitment

China

Contacts

• Name: Lina Hu, Hongwei Liu

• Name: West China Second University Hospital, S
• Affiliation: ??????????

Key inclusion & exclusion criteria

Inclusion criteria: 1. patients in accordance with diagnostic standards for vulvovaginal candidiasis;
2. Patients have sexual experience and not in menses. Age: 18-60;
3. Patients have no serious diseases, such as the heart, brain, liver, kidney and hematopoietic system diseases;
4. atients have no other vulvovaginal infection diseases as follow: trichomonad vaginitis and bacterial vaginosis;
5. Patients have not used any antifungal drugs during the last two weeks;
6. Patients have not used any vulvovaginal drugs and cleaners during the last two weeks;
7. Patients with good follow-up and compliant conditions should sign the Informed Consent Form.
Exclusion criteria: 1. Pregnant and nursing women;
2. Patients with abnormal Laboratory Test Results has clinical significance:
(1)ALT and AST are 3 times more than normal value;
(2)WBC<3.6*10^9/L;
(3)PLT<70*10^9/L;
(4)Abnormality of electrocardiogram has clinical significance;
(5)BUN and Cr are greater than normal value;
3. Patients allergy to investigational product and any other two or more drugs;
4. Patients participated other clinical trials during last three months;
5. Patients with alcohol or drug abuse experience;
6. Psychopath;
7. Patients have used antibiotics during the last two weeks;
8. Patients used to participate in this trial;
9. Patients have been treated for current vulvovaginal candidiasis;
10. Patients have been treated for other vulvovaginal diseases during the last two weeks;
11. Any other unsuitable reasons for the trial.

Age minimum: 18
Age maximum: 60
Gender: Female

Health Condition(s) or Problem(s) studied

Vulvovaginal Candidiasis

Intervention(s)

1:Butoconazole Nitrate Vaginal Suppository, 100mg, q.d. three days;2:Miconazole Nitrate Vaginal Capsules, 400mg, qd, three days;

Primary Outcome(s)

Clinical efficacy after treatment 7-14 days;Etiological efficacy after treatment 7-14 days;Clinical efficacy ,Etiological efficacy ,and Comprehensive efficacy after treatment 28-35 days;Comprehensive efficacy after treatment 7-14 days;

Source(s) of Monetary Support

Sino-American KUNMING DIHON PHARMACEUTICAL CO., LTD.