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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001039

Enrollment

Unknown

Registered

2010-09-26

Start date

2009-04-24

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvovaginal Candidiasis

Interventions

1:Butoconazole Nitrate Vaginal Suppository, 100mg, q.d. three days

2:Miconazole Nitrate Vaginal Capsules, 400mg, qd, three days

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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;	—

Countries

China

Contacts

Public ContactLina Hu, Hongwei Liu

cqhulina@126.com+86 028 85503063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026