SUMMARY
MetroGel-Vaginal®
(metronidazole vaginal gel)
0.75% Vaginal Gel
METROGEL-VAGINAL is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent.
METROGEL-VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as
Haemophilus
vaginitis,
Gardnerella
vaginitis, nonspecific vaginitis,
Corynebacterium
vaginitis, or anaerobic vaginosis).
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent
Lactobacillus
morphology, (b) predominance of
Gardnerella
morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and
Herpes simplex
virus should be ruled out.
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NEWS HIGHLIGHTSMedia Articles Related to Metrogel Vaginal (Metronidazole Vaginal)
Birth Control May Help Ward Off Bacterial Vaginosis
Source: MedicineNet Bacterial Vaginosis Specialty [2009.07.31]
Title: Birth Control May Help Ward Off Bacterial Vaginosis
Category: Health News
Created: 7/31/2009 7:00:00 AM
Last Editorial Review: 7/31/2009
Bacterial Vaginosis
Source: MedicineNet Chlamydia In Women Specialty [2009.02.18]
Title: Bacterial Vaginosis
Category: Diseases and Conditions
Created: 11/7/2001 1:44:00 PM
Last Editorial Review: 2/18/2009
What is Bacterial Vaginosis?
Source: MedicineNet metronidazole cream Specialty [2007.07.11]
Title: What is Bacterial Vaginosis?
Category: Doctor's Views
Created: 5/2/2005
Last Editorial Review: 7/11/2007
Published Studies Related to Metrogel Vaginal (Metronidazole Vaginal)
Comparison of oral and vaginal metronidazole for treatment of bacterial vaginosis in pregnancy: impact on fastidious bacteria. [2009.06.10]
BACKGROUND: Bacterial vaginosis (BV) is a common condition that is associated with preterm birth and acquisition of complex communities of vaginal bacteria that include several fastidious species. Treatment of BV in pregnancy has mixed effects on the risk of preterm delivery, which some hypothesize is due to variable antibiotic efficacy for the fastidious bacteria. Both oral and intravaginal metronidazole can be used to treat bacterial vaginosis in pregnancy, but little is known about the impact of different routes of antibiotic administration on concentrations of fastidious vaginal bacteria... CONCLUSION: Both oral and vaginal metronidazole therapy in pregnant women result in a significant decrease in concentrations of most BV-associated anaerobic bacteria, with the exception that Leptotrichia, Sneathia and BVAB1 do not significantly decrease with vaginal metronidazole therapy. These data suggest that the route of antibiotic administration has a minor impact on bacterial eradication in pregnant women with BV. TRAIL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT00153517.
A comparative study of the therapeutic effects of the Zataria multiflora vaginal cream and metronidazole vaginal gel on bacterial vaginosis. [2008.12]
Bacterial vaginosis (BV) is one of most prevalent complications among reproductive-aged women. Metromidazole prescription, which is considered as the first-line treatment of BV, is usually followed by a few side effects.
Therapy of metronidazole with azathioprine to prevent postoperative recurrence of Crohn's disease: a controlled randomized trial. [2008.10]
BACKGROUND & AIMS: More than 80% of Crohn's disease (CD) patients undergoing resection suffer recurrence of their disease. Therapy with aminosalicylates, antimetabolites, or antibiotics leads to a modest reduction in the incidence of recurrence. Goal: We sought to examine whether metronidazole for 3 months together with azathioprine (AZA) for 12 months is superior to metronidazole alone to reduce recurrence of postoperative CD in "high-risk" patients... CONCLUSIONS: Despite the enhanced risk of recurrence, the overall incidence of significant recurrence was rather low, probably owing to the metronidazole treatment that all patients received. Concomitant AZA resulted in lower endoscopic recurrence rates and less severe recurrences 12 months postsurgery, predicting a more favorable clinical outcome. This combined treatment seems to be recommendable to all operated CD patients with an enhanced risk for recurrence.
Clinical and microbiological benefits of systemic metronidazole and amoxicillin in the treatment of smokers with chronic periodontitis: a randomized placebo-controlled study. [2008.10]
AIM: The aim of this study was to evaluate the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with metronidazole (MTZ) or with MTZ and amoxicillin (AMX) in the treatment of smokers with chronic periodontitis... CONCLUSION: Significant advantages are observed when systemic antibiotics are combined with SRP in the treatment of smokers with chronic periodontitis. The greatest benefits in clinical and microbiological parameters are achieved with the use of SRP+MTZ+AMX.
Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. [2008.09.03]
OBJECTIVE: Metronidazole is the drug of choice for the treatment of bacterial vaginosis (BV). However, so far the oral administration has not been clinically compared to the intravaginal application regarding efficacy, side effects and patient satisfaction in a scientific sound fashion... CONCLUSION: In this clinical trial the intravaginal application was as effective as the oral administration of metronidazole in treating BV. However, significantly less adverse events were reported after short-term intravaginal as compared to oral application (p=0.023) and probably led to a better patient compliance.
Clinical Trials Related to Metrogel Vaginal (Metronidazole Vaginal)
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1% [Completed]
The purpose of this study is to determine the cosmetic appearance of metronidazole gel
(MetroGel®) 1% with commonly marketed facial foundations.
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment [Completed]
What is the difference between the use of one drug (Oral Metronidazole) versus the use of
this same drug combined with another drug (Rifampin) in treatment of bacteria and
infection-associated diarrhea in patients? This infection is an important cause of morbidity
and mortality in both the community and hospitals, and the leading cause of hospital and
chronic facility-acquired diarrhea. Research is important for the treatment of this
infection. Patient care with use of two medication treatment regimens will be studied.
Sequential Vaccinations in Prostate Cancer Patients [Active, not recruiting]
This study will evaluate, in two parts, the safety and effectiveness of vaccinations against
prostate cancer in patients with disease that has recurred or metastasized (spread beyond the
primary site) following standard treatment. The vaccine consists of three parts, or
ingredients. Part 1 is derived from the vaccinia virus, which has been used for many years
against smallpox. Part 2 is made from a related virus called fowlpox. Two kinds of human DNA
are put inside some of the vaccinia and fowlpox viruses-one produces PSA protein, which is
made by prostate cancer cells; the other produces various proteins called Tricom that enhance
immune activity. Part 3 of the vaccine involves a protein called Sargramostin (also called
granulocyte-macrophage colony stimulating factor, or GM-CSF), which boosts the immune system.
An experimental form of Sargramostin, in which the human DNA for GM-CSF is put inside the
fowlpox virus, is included in the regimen. Stage 1 of the study will examine the safety of
the vaccine and Stage 2 will examine its ability to produce an immune response against tumor
cells.
Patients 18 years of age or older with recurrent or metastatic prostate cancer may be
eligible for this study. Candidates will be screened with a medical history and physical
examination, blood and urine tests, and imaging studies, including computed tomography (CT)
of the chest, abdomen and pelvis. Candidates for Stage 2 will have a blood test to determine
tissue type (human leukocyte antigen, or HLA) type. Only patients with HLA-A2 type may
participate in Stage 2. Patients who are allergic to eggs may not participate in either
part.
Part 1 - Safety Study
Patients in Part 1 receive different combinations and dosages of vaccines. The specific
vaccine and dosage for an individual is determined by his or her time of entry in the study.
The first group of 3 to 6 patients receive fowlpox vaccine; group 2 patients receive vaccinia
and fowlpox; group 3, vaccinia, fowlpox and Sargramostin; group 4, vaccinia and fowlpox, and
group 5, vaccinia and fowlpox. All vaccines are injected under the skin. Patients receiving
the vaccinia and fowlpox vaccines have injections of one or the other once every 4 weeks for
3 months. Patients receiving Sargramostin in addition to fowlpox and vaccinia vaccines
receive the Sargramostin injections daily for 4 days, starting with the day of each vaccine
injection.
Part 2 - Immune Response Study
Patients in Part 2 are randomly assigned to one of four treatment groups, consisting of
different combinations or doses of vaccines to test the effects of the vaccines on the immune
system. The course of treatment is similar to that in Part 1. To obtain sufficient numbers of
immune system cells to measure immune response, patients undergo lymphapheresis-a procedure
for collecting lymphocytes (a type of white blood cell)-on days 1 and 85 of the study. For
this procedure, whole blood is collected through a needle in an arm vein and circulated
through a machine that separates it into its components. The lymphocytes are removed, and the
rest of the blood is returned to the patient through the same needle. For patients who do not
have good arm veins, lymphocytes are collected through a central line-a temporary catheter
(plastic tube) that is placed in a large vein in the neck or under the collarbone. Patients
whose disease remains stable and who tolerate the treatments well may continue to receive the
vaccines every 12 weeks. Patients are monitored closely throughout treatment with monthly
blood tests and with x-ray studies-including bone scans and CT scans of the abdomen and
pelvis-every 85 days.
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application [Completed]
This eight-hour kinetic regression clinical study was conducted to assess the ability of
MetroGel® 1% to deliver moisture to facial skin after a single application.
BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study [Recruiting]
Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost
patients time, energy, comfort and money. BV is associated with increased incidence of
sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour,
post-surgical infections, and endometritis. Current treatment for those women symptomatic
for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have
success rates of 70-80 % at 1 month after treatment. These treatments also have high
recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women)
that include secondary vaginal infection with candida. Intravaginal boric acid has been used
for >100 years for the treatment of vaginal infections and is quite commonly prescribed
today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an
effective treatment of other vaginal infections, such as candida. To date, there are no
clinical trials studying the effectiveness of boric acid in the treatment of BV.
Objectives: To determine whether boric acid is at least as effective and as safe as
metronidazole for treating women with symptomatic BV, our study will compare intravaginal
boric acid to the current standard intravaginal treatment, metronidazole, and to a placebo.
Our goal is to expand women's options for the treatment of BV. Hypothesis: Boric acid is an
effective treatment of bacterial vaginosis as compared to placebo. Boric acid is at least
as effective and as safe in the treatment of bacterial vaginosis as compared to
metronidazole.
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Page last updated: 2009-10-20
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