Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
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ClinicalTrials.gov Identifier: NCT01230814 |
Recruitment Status
:
Completed
First Posted
: October 29, 2010
Results First Posted
: September 26, 2014
Last Update Posted
: October 6, 2014
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Condition or disease | Intervention/treatment | Phase |
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Bacterial Vaginosis Candidiasis Trichomoniasis | Drug: Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate) Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 234 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
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Experimental: Arm 1
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month; 117 Subjects.
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Drug: Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
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.
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Placebo Comparator: Arm 2
Placebo suppositories nightly for five consecutive nights each month; 117 Subjects.
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Drug: Placebo
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.
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- Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC). [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
- Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV). [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent's criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.
- Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection). [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).
- Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria). [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 screening.
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Presence of bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or T. vaginalis infection at screening:
- BV: Microscopic criteria (Nugent's score greater than or equal to 7)
- VVC: Fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
- T. vaginalis infection: Identification of motile trichomonads on vaginal saline wet preparation.
- 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.
Exclusion Criteria:
- 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.
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History of medical condition that would contraindicate use of the study product
- Porphyria
- Epilepsy
- Serious liver disease or signs and symptoms consistent with serious liver disease including jaundice, ascites, esophageal varices, encephalopathy, and bleeding disorders.
- Renal failure
- History of adverse reaction to the study medications (intravaginal metronidazole or miconazole).
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Current use of medication that may interact with the study drug (due to vaginal absorption of study drug)
- Warfarin
- Phenytoin
- Phenobarbital
- Disulfiram
- Cimetidine
- Lithium
- Astemizole
- Terfenadine
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230814
United States, Alabama | |
University of Alabama at Birmingham Medical Center | |
Birmingham, Alabama, United States, 35294-0007 | |
Kenya | |
Women's Health Project - Ganjoni Municipal Clinic | |
Mombasa, Coast, Kenya | |
University of Nairobi - Center for STD/HIV Research & Training | |
Nairobi, Kenya | |
University of Nairobi - Kenya AIDS Vaccine Initiative | |
Nairobi, Kenya |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01230814 History of Changes |
Other Study ID Numbers: |
09-0070 DMID STI CTG 09-0070 PVI |
First Posted: | October 29, 2010 Key Record Dates |
Results First Posted: | September 26, 2014 |
Last Update Posted: | October 6, 2014 |
Last Verified: | September 2014 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Bacterial vaginosis, metronidazole, miconazole, vulvovaginal candidiasis, trichomonas vaginalis, women, Kenya |
Additional relevant MeSH terms:
Candidiasis Vaginal Diseases Vaginosis, Bacterial Trichomonas Infections Mycoses Genital Diseases, Female Bacterial Infections Vaginitis Protozoan Infections Parasitic Diseases Metronidazole Miconazole Anti-Infective Agents |
Antiprotozoal Agents Antiparasitic Agents Antifungal Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP3A Inhibitors |