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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
This study is currently Recruiting
August 2011 By National Institute of Allergy and Infectious Diseases (NIAID)
First Recieved on October 28, 2010
Last Updated on November 3, 2011
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.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Metronidazole plus Miconazole:Experimental|
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
Placebo suppositories nightly for five consecutive nights each month.
Vaginal suppositories, identical in appearance to the active product; contains Witepsol S 55 with no metronidazole or miconazole.
|Drug:Metronidazole plus Miconazole Nitrate Co-formula|
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. Dosing: nightly for 5 consecutive night each month.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Informed consent obtained and informed consent form (ICF) signed.
- Female, aged 18-45 years.
- Sexually active with greater than or equal to 4 episodes of sex with a male partner
during the past month.
- Human immunodeficiency virus (HIV)-seronegative on both HIV tests in parallel
- Presence of bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or T.
vaginalis infection at screening:
1. BV: Microscopic criteria (Nugent's score greater than or equal to 7)
2. VVC: Fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline
wet mount plus a positive culture showing yeast on Sabouraud's agar.
3. T. vaginalis infection: Identification of motile trichomonads on vaginal saline
- Able and willing to comply with study visit schedule and procedures during the
12-month period of follow-up.
- Able and willing to abstain from sex or to use non-latex condoms (provided) for 24
hours following insertion of each vaginal suppository.
- Willing to abstain from alcohol during, and for 48 hours after, treatment.
- Plan to remain in study area for the next year.
- Agree to not participate in other research studies involving drugs, medical devices,
or vaginal products for the duration of study.
- Currently pregnant (positive urine Beta-Human Chorionic Gonadotropin (hCG) or
planning to conceive during the next 12 months (by self-report).
- Currently breastfeeding.
- Within first 3 months post-partum.
- Current menstruation - women who are currently menstruating may be enrolled following
the completion of menses.
- History of 4 or more episodes of treatment for any vaginal infection in the past 12
months. This would be a cumulative total, including any treatment for bacterial
vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis
(TV) and/or syndromic.
- History of medical condition that would contraindicate use of the study product
3. Serious liver disease or signs and symptoms consistent with serious liver
disease including jaundice, ascites, esophageal varices, encephalopathy, and
4. Renal failure
- History of adverse reaction to the study medications (intravaginal metronidazole or
- Current use of medication that may interact with the study drug (due to vaginal
absorption of study drug)
- Current use of oral or intravaginal antifungal medication.
- Current use of oral or intravaginal metronidazole, tinidazole, or clindamycin.
- Current use of latex diaphragm.
- As determined by the investigator, a medical condition or situation exists such that
study participation would not be advisable.