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At least 55 records · Page 3Linked to original sources
PubMed1985

Treatment of vaginal candidosis with tioconazole 2% vaginal cream.

Six hundred and three women in a contraceptive clinic were examined for the presence of C. albicans in the vagina and questioned about symptoms. Twenty-nine women with C. albicans accompanied by symptoms were treated with tioconazole 2% in a vaginal cream for 3 days, repeated once after an interval of 1 week. The mycological cure rate was 88.5%. At the same time, 34 women with vaginal C. albicans but without symptoms were examined. The spontaneous cure rate in these patients was 58.8%. In the symptomatic group, rectal C. albicans was observed in 56.5% of patients before treatment. After vaginal treatment, a rectal cure rate of 100% was achieved, but with a recurrency frequency after 2-4 weeks of 17.4%. Comparative vaginal recurrency frequency was 10.3%. Three were not cured. The method used has shown itself to be very acceptable for the patient and to have a cure frequency that is fully equal to previously used, longer lasting treatments.

Adolescent↗
PubMed1981

[Intravaginal treatment of colpitis maculosa with an oestriol-containing vaginal cream (author's transl)].

43 patients with colpitis maculosa (average age 60.2 years) were selected for an open control therapeutic study with Ortho-Gynest vaginal cream (Ortho-Cilag). The cream contains 0.5 mg of oestriol per single applicator filling. The treatment lasted from 3 to 4 weeks, success being evaluated by clinical documentation and cytological evaluation of vaginal smears before and after treatment. 10 patients (23.3%) were treated successfully, 29 (67.4%) showed a distinct improvement both clinically and cytologically, whilst the remaining 4 (9.3%) showed only moderate improvement. Hence, 39 patients (90.7%) were classified as having been successfully or partly successfully treated. Severe symptoms disappeared completely or were greatly alleviated in 91.4% cases. Moderate symptoms vanished in 59.7%. 58.1% showed a complete normalisation of the former atrophic vaginal skin. Blood spotting and reddening of the vaginal wall vanished completely. A change from dry to moist vagina occurred in 77.3% patients. Discharge vanished completely in 80.6% cases. No untoward side effects were recorded.

Administration, Topical↗
PubMed1994

Endometrial hyperplasia: efficacy of a new treatment with a vaginal cream containing natural micronized progesterone.

Seventy-eight premenopausal women affected by benign endometrial hyperplasia (60 simple and 18 complex) were treated from the 10th to the 25th day of the menstrual cycle with a vaginal cream containing 100 mg of natural micronized progesterone in polyethylene glycol base. The treatment lasted 3 months in 58 patients and 6 in the other 16 patients. Four patients were lost from the study. We observed a total of 67 complete regressions (90.5%) of which 58 (78.3%) occurred in the first 3 months and 9 (11.5%) after 6 months of treatment. Simple hyperplasia showed a significantly higher response to treatment in comparison with the complex type (P < 0.001). The most frequent endometrial pattern detected in the patients in whom hyperplasia regressed was of a secretive type. Recurrence of hyperplasia occurred in 1 out of 58 (1.72%) patients at the 3rd month and in 3 out of 49 (6.1%) patients at the 6th month after treatment. There were no significant differences between the two hystological groups in the percentage of recurrence. During treatment we observed a significant reduction of the amount, duration and frequency of the menstrual bleeding. Minimal side-effects were observed. In conclusion, for its effectiveness and safety, vaginal administration of natural micronized progesterone seems to be an interesting approach to benign endometrial hyperplasia, particularly indicated in women also affected by metabolic disorders.

Administration, Intravaginal↗
PubMed2003

A mucoadhesive, cyclodextrin-based vaginal cream formulation of itraconazole.

The development of vaginal medications, especially antifungal medications, requires that the drug is solubilized as well as retained at or near the mucosa for sufficient periods of time to ensure adequate bioavailability. Itraconazole is a broad-spectrum antifungal agent, which has been used for some time orally and intravenously but for which a vaginal formulation has not yet been developed. We present here a novel itraconazole formulation intended for vaginal use based on hydroxypropyl-beta-cyclodextrin (HPbetaCD), a functional excipient that increases drug solubility and generates a mucoadhesive system in the presence of other ingredients. An aqueous phase was prepared by solubilizing itraconazole with HCl in the presence of propylene glycol and then adding an aqueous solution of HPbetaCD. After pH adjustment, the itraconazole/HPbetaCD solution was added to the oil phase (paraffin oil, trihydroxystearate, and cetyl dimethicon copolyol) and the desired cream containing 1%, 2%, and 2.5% drug obtained by homogenization. Primary irritation studies and subchronic toxicity studies using a rabbit vaginal model indicated that the formulation was safe, well tolerated, and retained in the vaginal space. Clinical investigations indicated that application of 5 g of a 2% cream was very well tolerated and itraconazole was not systemically absorbed. Additional studies in women found that the itraconazole cream was highly effective in reducing or eliminating fungal cultures with few adverse effects. These studies suggested that an HPbetaCD-based, emulsified wax cream formulation was a useful and effective dosage form for treating vaginal candidiasis.

2-Hydroxypropyl-beta-cyclodextrin↗
PubMed1981

Endocrinological and clinical investigations in post-menopausal women following administration of vaginal cream containing oestriol.

The maturation value (MV), cervical mucus parameters (ferning, Spinnbarkeit), oestrone (E1), oestradiol (E2), oestriol (E3), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), thyrotropin (TSH), growth hormone (GH), sex hormone binding globulin (SHBG), corticosteroid binding globulin (CBG) and thyroxin-binding globulin (TBG) were determined in 11 post-menopausal women presenting with vaginal atrophy prior to, and following, treatment with Ovestin vaginal cream containing 0.5 mg/day of E3 for 8 wk. In 6 of the patients E3 was measured during frequent plasma sampling on days 1, 21 and 56; in the same patients and on the same days TRH-stimulated PRL, TSH and GH levels were estimated. While the therapy induced a sharp rise in the MV, there was a moderate effect on ferning/Spinnbarkeit. Baseline E3 rose from undetectable levels to a mean value of 86.8 pmol/l at day 21. E3 levels achieved during frequent plasma sampling were higher on day 1 than on days 21 and 56 - a decline of the areas under the response curves being significant (P2-sided = 0.03). There was a slight suppression of FSH and LH. No changes in the circulating levels of E1, E2, SHBG, CBG, TBG, PRL, TSH and GH were seen. TRH-stimulated PRL, TSH and GH levels remained unaffected. Clinical effect was excellent and no untoward effects were reported.

Administration, Topical↗
PubMed1979

Safety and efficacy of micronized estradiol vaginal cream.

Fifty-four postmenopausal patients with atrophic vaginitis satisfactorily completed one to two months' therapy with daily intravaginal application of 0.2 mg of 17 beta-estradiol in a cream base. No significant alterations were noted in the hematologic biochemical, and urine analyses. A number of response criteria showed significant improvement (P less than .01), including the severity rating for atrophic vaginitis, the maturation index of vaginal cells, the frequency and severity of hot flashes, the presence of vaginal dryness and itching, dyspareunia, skin flushing, and the severity of sweating episodes. The incidence of side effects was low and included breast tenderness and abdominal cramping.

Adult↗
PubMedDate not supplied

[Estrogenic vaginal creams and calciuria in postmenopausal women].

In a group of 25 post menopausal women 50 - 75 years old (mean 57,2 years) the urinary calcium creatinine ratio was examined before and after four months of vaginal estrogen cream application. Estrogen well absorbed by the vaginal epithelium, lowered calcium excretion in urine from 200,12 mg/100 ml before treatment to 172,76 mg during treatment. Urinary Ca/ce ratio decreased from 0,25 before to 0,19 during treatment. A statistically significant p less than 0,01. In the light of our findings, the treatment can be recommended to menopausal women at risk of developing osteoporosis, even is cases of hyperlipidemia or mild diabetes mellitus. It is wise to add dietary calcium and physical exercises.

Aged↗
PubMed1999

Butoconazole nitrate 2% for vulvovaginal candidiasis. New, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate. Gynazole 1 Study Group.

OBJECTIVE: To compare the safety and efficacy of a single vaginal dose of a butoconazole nitrate 2% bioadhesive, sustained-release cream* (butoconazole 1-BSR) with a seven-day schedule of miconazole nitrate vaginal cream 2% (miconazole 7). STUDY DESIGN: The clinical trial was conducted according to a randomized, parallel, investigator-blind, multicenter study design. The patients self-administered the respective creams to the posterior vaginal fornix. Two hundred twenty-three patients started the trial and were analyzed for safety. A total of 205 patients qualified for efficacy analysis, 101 receiving butoconazole 1-BSR and 104 using miconazole 7. Patients receiving butoconazole 1-BSR inserted one applicator full of medication once. Those assigned to receive miconazole 7 inserted one applicator full daily for seven days. Patients were evaluated 7-10 and 30 days after completion of therapy. RESULTS: Butoconazole 1-BSR rapidly relieved the signs and symptoms of vulvovaginal candidiasis. The proportion of patients with severe symptoms declined from the pretreatment 20% to 6% on the 1st day, to 3% on the 4th day, and to 2-1% on the 5th-7th day after single-dose application. Eight to ten days after treatment completion, clinical symptoms regressed in 92%, and fungal cultures were negative in 87% of patients. At the 30-day posttreatment visit, 88% of patients remained clinically cured, and 74% had negative fungal cultures. In the miconazole 7 group, the proportion of patients with severe symptoms declined from 23% to 19% after the first dose; thereafter, symptom relief proceeded more rapidly. Eight to ten days after treatment completion, clinical symptoms regressed in 92% and fungal cultures were negative in 87% of patients. At the 30-day follow-up examination, 86% patients were clinically cured, and 77% were culture negative. After single-dose butoconazole 1-BSR, severe symptoms receded faster than after the first dose of miconazole 7, and the difference was statistically significant (P = .01). In all other efficacy parameters, the differences between the two groups were not statistically significant. Neither treatment regimen caused significant adverse events. CONCLUSIONS: This clinical trial demonstrated that butoconazole 1-BSR is an effective and safe alternative to longer-term therapy with miconazole nitrate (seven days) for vulvovaginal candidiasis.

Administration, Topical↗
PubMed1985

Treatment of vaginal candidosis using clotrimazole vaginal cream: single dose versus 3-day therapy.

The effect of using a single dose of 10% clotrimazole cream was compared with that of using a twice-daily application of 2% clotrimazole cream for 3 days in 111 women with mycologically proven vaginal candidosis. The results, analyzed for 55 patients in each group, showed that 1 week after starting treatment, negative cultures were recorded for 91% of the patients who received single-dose therapy and 96% of patients treated with the 3-day regimen. Five weeks after treatment started, the figures were 84% and 81%, respectively, showing that both regimens were equally effective. No adverse events were recorded for either preparation.

Administration, Topical↗