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At least 19 recordsLinked to original sources
PubMed2001

Comparison of clindamycin phosphate vaginal cream with triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

BACKGROUND: Triple sulfonamide vaginal cream has been used to treat bacterial vaginosis for many years. There are few studies in which triple sulfonamide cream has been compared with newer regimens. GOAL: To compare the efficacy and safety of clindamycin phosphate vaginal cream with that of triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. STUDY DESIGN: In this double-blind, randomized multicenter study, nonpregnant women 16 years of age or older with symptomatic bacterial vaginosis were assigned to receive either 2% clindamycin phosphate vaginal cream or triple sulfonamide vaginal cream for 7 days. Follow-up visits were conducted 5 to 10 days and 25 to 39 days after completion of treatment. RESULTS: Clinical cure or improvement at 25 to 39 days was noted in 55 (69.6%) of 79 assessable participants who received clindamycin vaginal cream and in 33 (41.8%) of 79 women who received triple sulfonamide vaginal cream (P < 0.0001). Most of the difference between the treatment groups was noted in women with a history of bacterial vaginosis. Among women without a history of bacterial vaginosis, clindamycin and triple sulfonamide creams had similar efficacy. Evaluation of Gram-stained vaginal smears correlated with clinical outcome. Most patients in both treatment groups reported an improvement in symptoms. No significant difference was observed between the treatment groups in the incidence of adverse events. CONCLUSION: Clindamycin 2% vaginal cream is more effective than triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.

Administration, Intravaginal↗
PubMed2000

[Effectiveness and safety of ciclopirox olamine 1% vaginal cream versus terconazole 0.8% vaginal cream in the treatment of genital candidiasis].

A multicenter randomized study was performed. One hundred and seventy patients were selected. The patients were 18 years and older. They presented signs and symptoms of genital candidiasis and had positive smear culture for Candida. Eighty five patients were assigned to receive Cicloprox olamine 1%, and eighty five patients were assigned to receive Terconazol 0.8%. The treatment lasted six days with the objective to compare the clinical and antifungal efficiency and safety with both treatments. The result of mixed efficiency (clinical and microbiology) for Cicloprox olamine was 48 cases (62.3%) at the end of the treatment were cured--day 7-; and at the continuation--day 21-42 of them had the same result (55.3%); improvement was seen at the end in 25 cases (32.5%) and at the continuation 21 cases had the same result (27.6%). For Terconazol the result was 45 cases (61.6%) were cured at the end of the treatment, and at the continuation 39 had the same result (57.4%); improvement was seen at the end in 23 cases (31.5%) and at the continuation 22 cases had the same result (32.4%). We conclude that both treatments are effective and well tolerated for genital candidiasis treatment.

Adolescent↗
PubMedDate not supplied

17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis.

OBJECTIVES: The efficacy and safety of 25-microg 17beta-estradiol vaginal tablets (Vagifem) were assessed and compared with 1.25-mg conjugated equine estrogen vaginal cream (Premarin Vaginal Cream) for the relief of menopausal-derived atrophic vaginitis, resulting from estrogen deficiency. DESIGN: In a multicenter, open-label, randomized, parallel-group study, 159 menopausal women were treated for 24 weeks with either vaginal tablets or vaginal cream. Efficacy was evaluated by relief of vaginal symptoms and concentrations of serum estradiol and follicle-stimulating hormone. Safety was monitored by the incidence of adverse events, evaluation of endometrial biopsies, and clinical laboratory results. Patients also assessed the acceptability of the study medications. RESULTS: Composite scores of vaginal symptoms (dryness, soreness, and irritation) demonstrated that both treatments provided equivalent relief of the symptoms of atrophic vaginitis. At weeks 2, 12, and 24, increases in serum estradiol concentrations and suppression of follicle-stimulating hormone were observed in significantly more patients who were using the vaginal cream than in those who were using the vaginal tablets (p < 0.001). Fewer patients who were using the vaginal tablets experienced endometrial proliferation or hyperplasia compared with patients who were using the vaginal cream. Significantly more patients who were using the vaginal tablets rated their medication favorably than did patients who were using the vaginal cream (p < or = 0.001). Patients who were receiving the vaginal tablets also had a lower incidence of patient withdrawal (10% versus 32%). CONCLUSIONS: Treatment regimens with 25-microg 17beta-estradiol vaginal tablets and with 1.25-mg conjugated equine estrogen vaginal cream were equivalent in relieving symptoms of atrophic vaginitis. The vaginal tablets demonstrated a localized effect without appreciable systemic estradiol increases or estrogenic side effects. Vaginal tablet therapy resulted in greater patient acceptance and lower withdrawal rates compared with vaginal cream therapy.

Administration, Intravaginal↗
PubMed1983

Tetracycline and amphotericin B vaginal cream for mixed vaginal infections.

A tetracycline and amphotericin B vaginal cream (Vagmycin; Squibb) was highly effective in mixed vaginal infections. More than 95% of patients had symptomatic relief while 85% showed bacterial and clinical response. There appeared to be little difference whether the cream was applied for 1 week or 2 weeks. A group of asymptomatic patients were evaluated to compare alterations in normal and pathological organisms as a result of treatment.

Amphotericin B↗
PubMed1978

Clinical evaluation of econazole nitrate in 1% vaginal cream for treatment of vaginal candidosis.

30 patients with mycologically confirmed vaginal candidosis on culture were treated with econazole vaginal cream (Gyno-Pevaryl) applied intravaginally once a day for 2 wk. 8 days after the end of treatment, mycological and clinical cures were demonstrated in 26 patients. Symptoms generally subsided rapidly, and the drug was well tolerated. This study confirms the efficacy of econazole in the treatment of vaginal candidosis.

Adolescent↗
PubMed1995

The potential effect on Neisseria gonorrhoeae of the use of clindamycin vaginal cream in the empirical treatment of vaginal discharge.

The minimum inhibitory concentrations (MIC) of clindamycin for 62 consecutive isolates of Neisseria gonorrhoeae were found to be 0.03-4 mg/L; the MIC50 and MIC90 were 0.125 and 2.0 mg/L respectively. Seven women treated with clindamycin vaginal cream had cervical mucus samples taken after seven days treatment. The concentrations of clindamycin achieved in the cervical mucus were 30-150 times higher (141-337 mg/L) than the highest MIC of the 62 N. gonorrhoeae isolates. Clindamycin vaginal cream is being used increasingly in Genitourinary Medicine clinics and General Practice for the treatment of bacterial vaginosis. This study shows that clindamycin vaginal cream achieves intra cervical concentrations that are high enough to inhibit N. gonorrhoeae. Empirical use of this therapy should be preceded by urethral and cervical swabs for N. gonorrhoeae in any woman at risk of gonorrhoeae.

Anti-Bacterial Agents↗
PubMed2000

Double-blind randomized dose-finding study in acute vulvovaginal candidosis. Comparison of flutrimazole site-release cream (1, 2 and 4%) with placebo site-release vaginal cream.

A double-blind randomized comparative phase II study of flutrimazole site-release vaginal cream (1, 2 and 4%) with placebo site-release vaginal cream was undertaken in patients with acute vulvovaginal candidosis. Vaginitis was demonstrated by both positive findings on microscopic examination of vaginal smears and positive culture as well as by the presence of clinical signs and symptoms. The vaginal monodose treatment was inserted in the evening at bedtime using a vaginal applicator and, in addition, all four groups of patients received additional topical external cream for application to the vulva twice-daily for 7 days; the placebo group received a placebo cream and the active therapy groups all received a 2% flutrimazole cream. A total of 133 patients who were seen over a 10-month period were screened and randomized: five patients did not take the allocated medication, and four patients whose menstrual period began shortly after study entry were excluded from the study, leaving 124 patients who were randomly allocated to receive a monodose vaginal 1% cream (regimen A, 28 patients), a monodose vaginal 2% cream (regimen B, 32 patients), a monodose vaginal 4% cream (regimen C, 31 patients) or a monodose vaginal placebo cream (regimen D, 33 patients). At the assessment 9 days after the end of therapy the proportion of patients who were cured was 82% in group A, 87.4% in group B, 83.8% in group C and 63.5% in group D. Three patients (10.7%) in group A, four (12.5%) in group B, one (3.2%) in group C and 12 (36.36%) in group D did not respond to the treatment. One patient (3.5%) in group A, and two patients (6.4%) in group C terminated the treatment prematurely due to intolerance. There was a significant association between Candida glabrata and treatment failure (P < 0.04) and C. glabrata and carrier state (P = 0.01) in vagina (chi 2 test, P = 0.01) and vulvovagina (chi 2 test, P = 0.00001). At the assessment 4 weeks after the end of therapy the proportion of cured patients was 60.6% in group A, 78% in group B, 80.6% in group C and 48.4% in group D. Group D (placebo) versus group B (2%) and group C (4%) showed a significant difference (P = 0.01 and P = 0.007, respectively). Although there were no significant differences in clinical and mycological activity between the three active groups, group B (flutrimazole 2% site-release vaginal cream) was chosen for clinical use due to its tolerance profile. Seven patients (25%) in group A, three (9.3%) in group B, two (6.4%) in group C and five (15.1%) in group D relapsed 4 weeks after the end of therapy; the relapse rate was not significantly associated with positive culture results 9 days after treatment. There was a significant association between C. glabrata and the carrier state (P < 0.01). The overall ineffective treatment (includes failures at control 1, relapses at control 2 and premature terminations) was 39% in group A, 21.7% in group B, 16% in group C and 51.3% in group D. There was a significant difference in the overall ineffective treatment when C and D groups were compared with placebo (P = 0.01 and P = 0.003, respectively).

Adolescent↗
PubMedDate not supplied

Ovestin vaginal cream and suppositories for the treatment of menopausal vaginal atrophy.

Eighty-two postmenopausal women with vaginal atrophy and associated symptoms were treated with either Ovestin vaginal cream (54 women) or vaginal suppositories (28 women) containing 0.5 mg of E3/dose, daily for 3 weeks. A maintenance dose of 0.5 mg of E3 twice weekly was applied by all patients for 5 weeks, and by 27 of them for up to 16 weeks. Variables studied were clinical and colposcopic findings, the Maturation Index (MI) and Maturation Value (MV), cervical mucus ferning (F) and spinnbarkeit (S) and endometrial biopsies (obtained pretreatment and after 3 weeks in 15 of the patients). Furthermore, the bio-availability of circulating unconjugated E3 for up to 8 hours following a single dose of Ovestin cream was studied in 10 of the patients. Clinical and colposcopic findings indicated that the treatment had a very favourable effect in all patients. This was reflected in the pronounced change in vaginal smears, indicating a strong oestrogenic effect. There was a slight to moderate effect on cervical mucus. Endometrial biopsies showed that endometrium remained atrophic in all 15 patients in whom biopsies were obtained. A maintenance dose of 0.5 mg of E3 twice weekly appeared to be sufficient to maintain the beneficial effect. Tolerance was good, and patients commented favourably on the treatment.

Adult↗
PubMed1991

[Use of phytostimolin vaginal cream and lavage in cervical dystrophy after DTC of the cervix].

The study evaluated the efficacy and tolerance of the active components of "phytostimolin" cream and vaginal lavage, Triticum Vulgare and Ether glycoethylen-mono-phenolic, in 40 patients suffering from dystrophic cervico-vaginal pathologies (group 1), and in 20 patients following DTC of the portio due to ectropion (group 2). The study was double blind. An overall efficacy of 70% was observed in group 1 and 90% in group 2. The results obtained, the absence of side effects, and the good level of tolerance confirm the value of the above components in the pathology in question.

Double-Blind Method↗
PubMed1979

Efficacy of estradiol vaginal cream in postmenopausal women.

In a double-blind parallel study daily intravaginal administration of conjugated estrogen cream and estradiol cream for 14 days relieved vasomotor and vaginal postmenopausal symptoms in 29 postmenopausal women. By day 14, therapy with the estradiol vaginal cream resulted in plasma estrone and estradiol levels closer to those in premenopausal women than therapy with the conjugated estrogen cream. The extent of improvement and final estradiol plasma levels in the estradiol vaginal-cream group correlated. There was no correlation with severity of symptoms or estradiol plasma level at baseline. The metabolism of the conjugated estrogen cream might account for absence of correlation between improvement and final estradiol plasma levels in the conjugated vaginal-cream group.

Administration, Topical↗
PubMed2001

Changes in the vaginal flora after two percent clindamycin vaginal cream in women at high risk of spontaneous preterm birth.

OBJECTIVE: To analyse alterationS in the vaginal flora after 2% clindamycin vaginal cream or placebo administered for the prevention of preterm delivery in high risk women. DESIGN: Observational study during a randomised multicentre double-blind placebo controlled trial. SETTING: Twelve city hospitals in The Netherlands. PARTICIPANTS: One hundred and sixty-eight women were enrolled. Alterations in the vaginal flora could be analysed in one hundred and twenty-four women by comparing the Nugent score on entry to the trial and at 31 weeks' gestation. The Nugent score was classified into normal, intermediate and bacterial vaginosis. INTERVENTIONS: Two percent clindamycin vaginal cream or placebo cream administered daily for seven days at week 26 of pregnancy. MAIN OUTCOME: Changes in the vaginal flora at week 31 of pregnancy. RESULTS: The placebo group consisted of 64 women and the clindamycin group of 60 women. At week 31 the vaginal flora was similar to week 26 with placebo cream but changed from normal vaginal flora to intermediate or bacterial vaginosis with 2% clindamycin vaginal cream. CONCLUSION: Obstetricians should not prescribe 2% clindamycin vaginal cream to pregnant women with normal vaginal flora in order to reduce the incidence of preterm birth. because it has no beneficial effects and is actually harmful. 2% Clindamycin vaginal cream encourages the presence of bacterial vaginosis which is epidemiologically associated with preterm birth.

Administration, Intravaginal↗
PubMed1995

Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream.

BACKGROUND: Treatment options for bacterial vaginosis are numerous. The purpose of this study was to compare the efficacy of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream for the treatment of bacterial vaginosis using traditional clinical and laboratory methods, as well as a new DNA probe test. We also determined the percentage of patients receiving each treatment who developed posttreatment vaginal candidiasis, a potential complication of treating bacterial vaginosis. METHODS: One hundred one women in whom bacterial vaginosis was diagnosed by standard criteria were randomly assigned to receive: oral metronidazole 500 mg twice daily for 1 week, 0.75% metronidazole vaginal gel 5 g twice daily for 5 days, or 2% clindamycin vaginal cream 5 g once daily for 7 days. Women with coexisting vulvovaginal candidiasis or vaginal trichomoniasis were excluded. Tests of cure by vaginal saline wet prep and potassium hydroxide microscopic examinations, Gram's stain, pH and DNA probe tests for Gardnerella vaginalis and Candida species were scheduled 7 to 14 days following treatment. RESULTS: There were no statistically significant differences in cure rates for oral metronidazole (84.2%), metronidazole vaginal gel (75.0%), or clindamycin vaginal cream (86.2%) (chi 2 = 1.204, df = 2, P = .548) using traditional clinical and laboratory criteria. Cure rates were lower based on DNA testing, indicating that Gardnerella vaginalis may remain after a clinical cure. This would explain cases of recurrent disease. Posttreatment vulvovaginal candidiasis was experienced by 12.5% of subjects treated with oral metronidazole, 14.8% of subjects treated with clindamycin vaginal cream, and 30.4% of subjects treated with metronidazole vaginal gel (chi 2 = 2.607, df = 2, P = .272). CONCLUSIONS: Oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream achieved nearly equivalent cure rates for the treatment of bacterial vaginosis. Patients treated with these agents experienced similar rates of posttreatment vulvovaginal candidiasis, but those using the intravaginal products reported being more satisfied with the treatment.

Administration, Intravaginal↗
PubMed1998

Clostridium difficile toxin-induced colitis after use of clindamycin phosphate vaginal cream.

OBJECTIVE: To report a case of toxin-positive Clostridium difficile-induced colitis (CDIC) after use of clindamycin phosphate vaginal cream. CASE SUMMARY: A 25-year-old postpartum white woman developed multiple watery stools and abdominal cramping on day 6 of therapy with clindamycin vaginal cream for bacterial vaginosis. She received no other concomitant medications. The patient's stool sample was found to be positive for the C. difficile toxin. Due to the costs and risks of standard therapy, we decided to manage the patient supportively. Complete resolution of the diarrhea occurred shortly thereafter. DISCUSSION: No published clinical studies in patients receiving clindamycin vaginal cream for bacterial vaginosis have documented C. difficile toxin in stool samples of patients with diarrhea. Approximately 5-6% of intravaginal clindamycin is absorbed in the bloodstream, making systemic effects possible. CONCLUSIONS: This report indicates clindamycin phosphate vaginal cream as the most probable cause of CDIC due to the temporal relationship between the occurrence of diarrhea and clindamycin administration, lack of concomitant medications, and documentation of C. difficile toxin.

Adult↗
PubMed1983

A clinical evaluation of treatment with estriol vaginal cream versus suppository in postmenopausal women.

Thirty postmenopausal women with vaginal atrophy were treated with a vaginal cream or vaginal suppositories containing 0.5 mg estriol (OvestinR, Organon, The Netherlands). The preparations were given daily for 14 days and then during the next 6 weeks a maintenance dose was applied twice a week. Cervical mucus, vaginal cytology and the endometrium were studied. Blood samples were analysed for unconjugated and conjugated estriol, FSH, LH, prolactin and sex hormone binding globulin capacity, before and after 2 weeks of treatment. Subjective relief of vaginal symptoms was reported by all patients. Restoration of vaginal mucosa was confirmed by colposcopy. Some women noted a feeling of transient "vaginal heat" during the first days of treatment; otherwise no side effects were reported. Higher values for Spinnbarkeit, ferning and karyopyknotic index were found for the cream group on day 14. No endometrial stimulation was detected as judged by light microscopy in any of the samples. No significant differences between the preparations were found for any of the hormone variables, or sex hormone binding globulin capacity, except for prolactin levels after 2 weeks of treatment. Possible reasons for the disparity between the two preparations regarding peripheral variables are discussed.

Aged↗
PubMed1992

Clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis: a prospective double-blind clinical trial.

Bacterial vaginosis is common among patients seen by gynecologists. Several types of therapy have been proposed. The purpose of this prospective, randomized, double-blind clinical trial was to examine the efficacy of clindamycin vaginal cream for the treatment of bacterial vaginosis. Sixty patients with symptoms of bacterial vaginosis were randomized into the study, and 46 completed the protocol. Twenty-three patients received 2% clindamycin vaginal cream (5 g applied intravaginally at bedtime for 7 days), with placebo oral tablets twice daily for 7 days. The other 23 patients received oral metronidazole tablets (500 mg twice a day for 7 days) and placebo vaginal cream (5 g intravaginally for 7 days). The cure rates for the two regimens were comparable. Twenty-two (97%) of the patients treated with clindamycin vaginal cream had improvement or cure at the first follow-up visit versus 19 (83%) of those taking metronidazole. There was no statistically significant difference between the two results. Side effects for both regimens were comparable. We conclude that 2% clindamycin vaginal cream offers similar efficacy and safety to standard oral metronidazole therapy for bacterial vaginosis.

Administration, Intravaginal↗