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A randomized, multicenter, parallel controlled clinical trial to evaluate the efficacy of ketoconazole suppository in the treatment of severe vulvovaginal candidiasis with miconazole nitrate vaginal soft capsule (Daknin) as positive control drug

A randomized, multicenter, parallel controlled clinical trial to evaluate the efficacy of ketoconazole suppository in the treatment of severe vulvovaginal candidiasis with miconazole nitrate vaginal soft capsule (Daknin) as positive control drug

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061450
Enrollment
Unknown
Registered
2022-06-25
Start date
2022-05-16
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Severe vulvovaginal candidiasis(VVC)

Interventions

Experimental group:Ketoconazole suppository, 1 capsule per night for 6 days
Control group:Miconazole nitrate vaginal soft capsule, 1 capsule per night for 6 days

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients with severe VVC whose symptom and sign scores >=7; 2. Women aged 18-50 years, married or have a sexual history and are not menstruating; 3. Women of reproductive age agreed to use barrier contraception during the study period; 4. Volunteer and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients; 2. Allergic to the pharmaceutical ingredients used in the research; 3. Patients with trichomoniasis vaginitis and bacterial vaginosis; 4. Patients who have used systemic antifungal drugs in the last three months and vulvovaginal antifungal drugs in the last two weeks; 5. Those who have received treatment for other vulvovaginal diseases or had vaginal lavage in the past two weeks; 6. Suspected cervical malignant lesions; 7. Systemic use of glucocorticoid or immunosuppressant within three months; 8. Participated in other drug clinical researchers within three months; 9. Other reasons cited by the researchers for not being included.

Design outcomes

Primary

MeasureTime frame
Total clinical effective rate (improvement rate of symptom and sign score >=67% and mycological test negative) ;

Countries

China

Contacts

Public ContactZhang Dai

Peking University First Hospital

mailzhangdai@sina.com+86 13910552191

Outcome results

None listed

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