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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

Phase 4
Completed
Conditions
Women aged 18-45 years oldNot an immunocompromisedhost Bacterial vaginosis treatment in previous 3 monthsNot taking these certain medications in the previous 1 month e.g. anti-parasitics, antibiotics
bacterial vaginosis, vaginal tablet, metronidazole
Registration Number
TCTR20200902002
Lead Sponsor
Faculty of Medicine Siriraj Hospital
Brief Summary

Vaginal tablets containing metronidazole 750mg plus miconazole nitrate 200mg shows non-significant superiority to 2g oral metronidazole in treating BV with comparable side effects.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
70
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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