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Comparative study of the effectiveness of Vaginal tablet : Metronidazole 750mg and Miconazole 200 mg and Oral Metronidazole for the treatment of Bacterial vaginosis : Randomized controlled trial

Comparative study of the effectiveness of Vaginal tablet : Metronidazole 750mg and Miconazole 200 mg and Oral Metronidazole for the treatment of Bacterial vaginosis : Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200902002
Enrollment
80
Registered
2020-09-02
Start date
2019-04-29
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

Women aged 18-45 years old Not an immunocompromised host Bacterial vaginosis treatment in previous 3 months Not taking these certain medications in the previous 1 month e.g. anti-parasitics, antibiotics bacterial vaginosis, vaginal tablet, metronidazole

Interventions

After diagnosis of Bacterial vaginosis, the patient in this arm get 7-day course of once daily 750g-Metronidazole with 200mg-Miconazole vaginal suppository. We performed history taking, Pelvic examina
Experimental Drug,Experimental Drug
Vaginal tablet : Metronidazole 750mg and Miconazole 200 mg,2g of Oral Metronidazole

Sponsors

Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 18-45 years old Diagnosed Bacterial vaginosis with Amsel criteria Can avoid sexual intercourse during 7-day course of treatment in vaginal suppository group Not an immunocompromised host

Exclusion criteria

Exclusion criteria: Had Bacterial vaginosis treatment in previous 3 months Taking these certain medications in the previous 1 month e.g. anti-parasitics, antibiotics, immunosuppressants, steroids, vaginal medications, anticoagulants, disulfiram Abnormal uterine bleeding Being pregnant or lactating or having menstruation during the diagnosis and treatment Frequently perform vaginal douching Currently having sexual transmitted disease Currently on the cervical intraepithelial neoplasia treatment or cervical cancer

Design outcomes

Primary

MeasureTime frame
clinical cure from signs and symptoms improvement 14 days sign and symptom score,clinical cure from Amsel's criteria improvement 14 days Amsel's criteria evaluation

Secondary

MeasureTime frame
satisfaction of the treatment 14 days, 1 and 3 months satisfaction score,adverse effects of the treatment 14 days, 1 and 3 months adverse effects,Recurrence 1 month sign and symptom score at 1 month

Countries

Thailand

Contacts

Public ContactManopchai Thamkhantho

Siriraj Hospital

manopchai.tha@mahidol.ac.th66819323378

Outcome results

None listed

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