At a glance
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A Double-Blind, Randomized Trial of Monthly Treatment With Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories Versus Placebo for Preventing Vaginal Infections in HIV-seronegative Women
In Brief
A Phase 2 clinical trial evaluating Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate) and Placebo for Bacterial Vaginosis and 2 related conditions. Completed, enrolled 234 participants across 4 sites in 2 countries.
Detailed Summary
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment. Researchers want to know if using vaginal suppositories can decrease the risk of vaginal infections. Participants will include 234 women who are sexually active (greater than or equal to 4 episodes of sex with men during the past month), HIV-negative, 18 to 45 years old, with bacterial infection \[vaginosis and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis\] detected by laboratory testing at a screening visit. Women will receive vaginal suppositories containing drug or inactive ingredients (placebo). Participation in the study will be about 12 months. Study procedures include: urine and blood tests, physical exams, and questionnaires.
Study Details
Timeline
Interventions
Neo-Penotran® Forte (active ingredient Metronidazole \& Miconazole Nitrate), co-formulated vaginal suppositories containing metronidazole 750 mg with miconazole 200 mg and excipients (Witepsol S 55). Witepsol S 55 is a hard fat suppository base. Such bases consist mainly of triglyceride esters of the higher saturated fatty acids along with varying proportions of mono- and diglycerides. 117 subjects receive nightly for 5 consecutive night each month.
Placebo vaginal suppositories, identical in appearance to the active product; contains Witepsol S 55, Titanium Dioxide and D+C yellow #10 with no metronidazole or miconazole.117 subjects receive nightly for 5 consecutive nights each month.