Phase 2
N=234
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Bacterial Vaginosis · Candidiasis · Trichomoniasis
Bottom Line
View on ClinicalTrials.gov: NCT01230814 ↗Enrolled (actual)
234
Serious AEs
1.7%
Results posted
Sep 2014
Primary outcome: Primary: 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). — 10.4; 11.3 percentage of follow-up visits — p=0.690
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
10.4; 11.3 | 0.690 |
| PRIMARY 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). |
21.2; 32.5 | 0.005 sig |
| SECONDARY 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). |
32.6; 46.5 | — |
| SECONDARY 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). |
14.4; 18.2 | — |
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.
Eligibility Criteria
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.
- 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.
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT01230814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.