MONISTAT 3 SUMMARY
MONISTAT 3™ (miconazole nitrate, 200 mg)
Vaginal Suppositories
MONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. Miconazole nitrate for vaginal use is also available as MONISTAT 7 Vaginal Cream and MONISTAT 7 Vaginal Suppositories.
MONISTAT 3 Vaginal Suppositories are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy and in diabetic patients has not been established. As MONISTAT is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis [Gardnerella]) should be ruled out by appropriate laboratory methods.
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NEWS HIGHLIGHTS
Published Studies Related to Monistat 3 (Miconazole Vaginal)
Safety and efficacy of bedtime versus daytime administration of the miconazole nitrate 1200 mg vaginal ovule insert to treat vulvovaginal candidiasis. [2005.01]
OBJECTIVE: Most vaginal products are self-administered at bedtime. Safety, efficacy, and ' therapeutic cure with bedtime versus daytime treatment of vulvovaginal candidiasis (VVC) were assessed to potentially improve compliance and convenience with vaginal antifungal treatment... CONCLUSION: The efficacy against a broad spectrum of pathogens and acceptability of daytime and bedtime administration of miconazole nitrate 1200 mg vaginal ovule were similar. These findings offer women a convenient option for treatment for WC, whether self-managed or managed by their healthcare provider.
Comparison of dermatopharmacokinetic vs. clinicial efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans. [2002.03]
PURPOSE: To compare the dermatopharmacokinetic vs. clinical trial methods for bioequivalence assessment of two miconazole nitrate vaginal cream, 2% products... CONCLUSION: The dermatopharmacokinetic method allowed simultaneous evaluation of both products in the same subject, within the same study period, and was more sensitive and discriminating in the assessment of bioequivalence between the two miconazole nitrate vaginal cream, 2% products than the clinical trial method.
[Efficacy and tolerance of 200 mg of fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis] [2002.02]
OBJECTIVE: Fenticonazole is an imidazole derivative with a broad-spectrum antifungal activity mainly against Candida albicans. Fenticonazole nitrate was compared to myconazole vs. test efficacy, tolerance and treatment compliance in-patients with mycotic vulvovaginitis... CONCLUSION: The results showed that both drugs are equally efficient in treating signs and symptoms of the infection as well as equally effective in the microbiological elimination of the causing agents of the mycotic vulvovaginitis.
Single-dose miconazole nitrate vaginal ovule in the treatment of vulvovaginal candidiasis: two single-blind, controlled studies versus miconazole nitrate 100 mg cream for 7 days. [2000.05]
To determine the efficacy and safety of a single-dose (1200 mg) soft gel insert (vaginal ovule) with miconazole nitrate (2%) topical cream compared with Monistat 7 (miconazole nitrate 2%) Vaginal Cream (Advanced Care Products, North Brunswick NJ) in treating vulvovaginal candidiasis (VVC), two randomized, single-blind, multicenter, controlled, comparative phase III studies were performed...
A comparative clinical evaluation of econazole nitrate, miconazole, and nystatin in the treatment of vaginal candidiasis. [2000.01]
A controlled triple open clinical study on three vaginal tablets--Econazole nitrate, Miconazole and Nystatin, was carried out. Seventy-five patients, aged between 18 and 45 years, presenting with mycologically proven cases of vaginal candidiasis, met certain set criteria and were admitted into the study.
Clinical Trials Related to Monistat 3 (Miconazole Vaginal)
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches [Not yet recruiting]
Background: Oral candidiasis is most frequently found among the elderly .It is accompanied
with oral pain, irritation, burning sensation. In addition, the altered taste sensation may
cause nutrition compromise, which may affect ones diet. Management of superficial oral
Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is
given five times per day with instruction to slowly suck on it with out the dentures.
Working hypothesis and aims: Management of oral candidiasis is feasible. The major
disadvantage of the mode of action now days is the substantively of the drug in the oral
cavity and patient compliance. A sustained release varnish which is easily applied on the
dentures, which also release the anti fungal drug for at least a day, may overcome some of
the pit falls of the treatment applied today.
Based on our past experience, in developing local sustained release varnishes for dental
use, we anticipate that we can also formulate a special anti fungal sustained release
varnish which will fit the special and unique needs of the elderly population.
Methods: Sustained release varnish will be developed in our laboratory. The kinetics of
release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The
formulation showing the optimal results will be tested on human subjects with oral
candidiasis. The efficacy of the varnish will be examined clinically (reduction in
symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in
vivo).
Expected results: The clinical out come of one time varnish application will be improved
compared to the five times application of lozenges (used today). The severity of the
disease should decrease and the healing period should be shorten drastically.
Importance: This is a novel pharmaceutical development of a local application of a dental
varnish designed specially to the elderly population
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients [Completed]
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg
(1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days
of treatment (at the test of cure visit, at Day 17-19).
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) [Completed]
To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches
(lozenges) as prophylaxis (preventive treatment) against fungal infections in patients
enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and
serious bacterial infection). Primarily, to compare the rates of invasive infections by C.
neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal
infections between two antifungal prophylactic treatments. Secondarily, to assess the effect
of prophylaxis on the incidence of severe fungal infections, defined as invasive infections
and esophageal candidiasis and less severe mucocutaneous infection.
Serious fungal infections are significant complicating and life-threatening occurrences in
patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such
patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly,
esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and
coccidioidomycosis also cause significant illness and death in AIDS patients. Once
established, fungal infections in AIDS patients generally require continuous suppressive
therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has
a number of characteristics that would make it a logical candidate to examine as a
prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to
be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and
coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis
appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans [Recruiting]
The purpose with this study, is to study the uptake of the pharmaceutical antifungal
miconazole when used as a vaginal suppository in young women. We want to know if the uptake
is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).
Clotrimazole Enemas for Pouchitis in Children and Adults [Recruiting]
Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients
with ulcerative colitis that is resistant to existing medical therapies. The development of
inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the
most common long-term complication of this procedure and can affect 50-60% of adults and
children. We have previously demonstrated that clotrimazole (delivered as a rectal
suppository) is generally safe, effective, and displays poor systemic absorption when used
in pediatric and adults with active pouchitis. We saw clinical benefit in patients with
pouch disease that had previously failed to respond to standard antibiotic, steroid, or
immunosuppressive therapies. The clinical trial outlined here will define the effectiveness
and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged
greater than two years) and adult patients with pouchitis.
Subjects in this study will be randomly assigned to receive either placebo (no active drug,
4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or
4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to
continue their existing anti-inflammatory medications during their participation in the
study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will
undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month
of study therapy, and pouch disease activity will be graded at after each procedure using
the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop
in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole
treatment group is not significant, and no subject experiences what are determined to be
study-related adverse effects, a second cohort of subjects will be recruited and studied
after receiving one month of either placebo (4 subjects), 6000 mg/day clotrimazole (8
subjects), or 7500mg/day clotrimazole (8 subjects).
Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole
blood levels will be measured during the first and last day of study participation. In
addition, adults will complete a health related quality of life assessment at baseline and
after completing study drug therapy.
All subjects will be eligible for one month of open-label study drug therapy after
completing one month of study drug therapy.
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Page last updated: 2007-05-02
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