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Clinical Trials/TCTR20200902002
TCTR20200902002
Completed
Phase 4

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

Faculty of Medicine Siriraj Hospital0 sites70 target enrollmentSeptember 2, 2020

Overview

Phase
Phase 4
Intervention
Not specified
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
Sponsor
Faculty of Medicine Siriraj Hospital
Enrollment
70
Status
Completed
Last Updated
last year

Overview

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.

Registry
who.int
Start Date
September 2, 2020
End Date
July 29, 2020
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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