Prevention of Persistence of Bacterial Vaginosis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Embil Pharmaceutical Co. Ltd
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• women 18-40 yrs old

• abnormal vaginal discharge or malodor

• positive QuickVue test

• positive KOH whiff test

• Positive finding of clue cells greater than or equal to 20% on wet mount

• Able to give informed consent

• willing to abstain from alcohol during the 5 day therapy and 1 day following

Exclusion Criteria:

• immunocompromised women

• symptomatic VVC

• pregnancy or positive pregnancy test

• menstruating or breastfeeding women

• other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks

• women with MPC, PID