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Effect of adding the second dose of sertaconazole 300mg vaginal ovule for treating pregnant women with acute vaginal candidiasis who were treated with a 300mg sertaconazole vaginal ovule: a randomized controlled trial

Effect of adding the second dose of sertaconazole 300mg vaginal ovule for treating pregnant women with acute vaginal candidiasis who were treated with a 300mg sertaconazole vaginal ovule: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220121004
Enrollment
110
Registered
2022-01-21
Start date
2022-02-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None listed

Interventions

Vaginal suppository at the clinic,Vaginal suppository at the clinic and the second dose at 7 days
Active Comparator Drug,Active Comparator Drug
Sertaconazole 300mg vaginal ovule,Two doses of sertaconazole (7 days apart)

Sponsors

Pacific Health Care (Thailand)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 and more years 2. Pregnancy GA 20-34 weeks 3. Diagnosis with vaginal candidiasis by microscope

Exclusion criteria

Exclusion criteria: 1. Abnormal uterine bleeding or abnormal vaginal discharge 2. Having at least 4 times in preceding year 3. Contraindication for imidazole such as liver disease, allergy 4. Cannot understand Thai 5. Being treated with imidazole in preceding month 6. Diabetes mellitus being on insulin 7. Immunocompromised condition

Design outcomes

Primary

MeasureTime frame
Microscopic cure 2 weeks following treatment Examination under microscope—

Secondary

MeasureTime frame
Duration of symptom improvement 2weeks Questionnaire,Side effects and satisfaction 2weeks questionnaire—

Countries

Thailand

Contacts

Public ContactManopchai Thamkhantho

Faculty of Medicine Siriraj Hospital, Mahidol University

tmanopchai@hotmail.com024194775

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026