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Intermittent prophylactic treatment of recurrent vaginal candidiasis by postmenstrual application of a 500 mg clotrimazole vaginal tablet.

The therapeutic efficacy of intermittent, monthly, postmenstrual prophylaxis with a single 500 mg clotrimazole vaginal tablet (n = 33) was compared with placebo tablets (n = 29) in 62 woman (age 28.1, SD 7.2 years) with recurrent vulvovaginal candidiasis. The number of episodes of acute vulvovaginal candidiasis experienced during the year prior to inclusion was 6.3, SD 1.9. The cumulative recurrence frequency after 6 months intermittent prophylaxis with clotrimazole (30.3%) was lower (p less than 0.001) than that recorded for the women who received placebo (79.3%). After an additional 6 months observation period without treatment there was no significant difference in the cumulative recurrence frequency between the groups (clotrimazole 84.9%; placebo 86.2%). The vagina was recolonised with Candida albicans in 70% of the women after 6 months prophylactic treatment with clotrimazole and in 86% of the women who had received placebo. Thus, this study has demonstrated that postmenstrual prophylactic treatment with a single 500 mg clotrimazole vaginal tablet, applied monthly, prevents recurrence of symptoms, although it does not eliminate yeasts from the vagina.

Administration, Intravaginal↗

Pharmacokinetics of natural progesterone vaginal suppository.

Natural and synthetic progesterone have been used to treat luteal insufficiency, premenstrual syndrome, and in infertile patients. The transvaginal route has advantages, such as lack of local pain, avoidance of first-pass hepatic metabolism, rapid absorption, high bioavailability and local endometrial effect. The aim of this study was to evaluate the pharmacokinetic of natural progesterone administered as vaginal suppositories of 25, 50 or 100 mg. Thirty-five healthy ovulating patients, 31.54 +/- 1.29 (mean +/- SEM) years old, in the follicular phase of the menstrual cycle (between days 7 and 10) participated in the study. They were separated in three groups and received vaginal suppositories containing either 25, 50 or 100 mg of natural progesterone. Progesterone serum concentration reached maximal levels within 2 or 3 h after the administration and was similar for the three groups (7.27 +/- 2.8 ng/ml; 8.84 +/- 3.14 ng/ml; 9.82 +/- 9.8 ng/ml, respectively). This study demonstrated that vaginally administered progesterone could reach levels that are similar to those obtained in ovulatory and luteal phases. The progesterone regimen for adequate endometrial protection and in vitro fertilization (IVF) programs still remains to be studied.

Administration, Intravaginal↗

[Topical one-time therapy with ketoconazole: a double-blind randomized study in vaginal mycosis].

In a double-blind clinical study 90 women with vaginal candidosis were randomly assigned to treatment with either single-dose ketoconazole (400 mg or 800 mg) or placebo vaginal suppositories. Microscope checks of vaginal fluid and mycological cultures were performed one week and four weeks after the treatment. The four weeks observation period gave no evidence for any significant differences among the three groups regarding symptoms reported as well as clinical picture and microscopy findings. Cure rate after one week, as determined by fungal cultures, was significantly lower in the placebo group (43%) than in the 400 mg (60%) and 800 mg groups (76%; p = 0.031). The mycological cure rate after four weeks did no longer show a significant difference between the groups tested, being 47% in the placebo group and 67% in each of the ketoconazole groups. Treatment of the sexual partner as well as predisposing factors did not influence the therapeutic effect. Due to the low ketoconazole serum concentrations after absorption of single vaginal doses, topical ketoconazole treatment can be applied in pregnancy. It remains to be tested, however, whether repeated vaginal application over three to five days will render higher and longer-lasting cure rates.

Administration, Intravaginal↗

[Comparison of the effectiveness of prostaglandin E2 gel in evening and morning induction of labor].

100 women participated in an open randomised study. 50 of them received 0.5 mg PGE2 in 2.5 ml Triacetin gel (Prepidil) intracervically in the morning (6.00 a.m.) and 50 at night (10.00 p.m.). The success rate was 74% (37 of 50) in the treatment group of the night compared with 52 (26 of 50) in the group of morning labor induction. A second dose after 8 hours was necessary in 26% (13 of 50) in the night group and in 48% (24 of 50) of the morning labor induction. Labor induction failed completely in 32% of the morning and in 12% of the night group. The induction time for contractions was 2 hours shorter after night labor induction, in primiparae the duration of first stage was 2 hours shorter but in multiparae there was no difference between the groups. There was also no difference in intrapartum and postpartum complications between the groups. In conclusion the induction of labor with intracervical PGE2 at night seems to be more effective without increasing the rate of complications.

Administration, Intravaginal↗

Vaginal misoprostol administered at home after mifepristone (RU486) for abortion.

BACKGROUND: There have been no US studies published on the effectiveness, safety, time to bleeding, and acceptability of misoprostol administered by vagina at home and repeated, if needed, after mifepristone was administered for abortion in women up to 8 weeks pregnant. METHODS: A prospective trial was conducted with women up to 8 weeks pregnant wanting an abortion. After receiving mifepristone 600 mg orally, subjects self-administered vaginal misoprostol 800 micrograms at home 2 days later. Subjects returned within 7 days, and if the gestational sac was still present on ultrasound, a repeat dose of misoprostol was administered in the office. Subjects completed a daily symptom log and a questionnaire on the acceptability of the procedures. RESULTS: Of the 166 subjects, 163 (98%) had a complete medical abortion. Three subjects presented with persistent bleeding and an incomplete abortion from 27 to 35 days after taking mifepristone and required surgical intervention. Vaginal spotting or bleeding occurred in 104 (62%) subjects before taking misoprostol, and 18 (11%) did not use misoprostol. Bleeding occurred on average 3.5 hours (SD, 3.2) after taking misoprostol. Six (4%) subjects required a second dose of misoprostol. Gastrointestinal side effects were common, mild, and brief. One hundred fifty-nine (96%) subjects agreed that the procedure went well, and 146 (90%) agreed that home administration of misoprostol was acceptable. CONCLUSIONS: Two days after taking mifepristone, misoprostol administered by vagina was found to be safe, highly effective, and acceptable to women. Since only 6 subjects needed a second dose of misoprostol, conclusions about repeat doses are not possible. This procedure is a promising alternative to surgical abortion.

Abortifacient Agents, Nonsteroidal↗

Induction of labor in great grandmultipara with misoprostol.

OBJECTIVE: To compare the efficacy and complications of intravaginal misoprostol application with oxytocin infusion for induction of labor in great grandmultiparous pregnancies with a Bishop score of <6. STUDY DESIGN: Sixty-four great grandmultiparous (delivering the tenth, or greater, infant) pregnant patients with a Bishop score of <6 were randomized in two groups with 32 patients receiving 50 microg intravaginal misoprostol four times with 4h intervals, and 32 patients receiving oxytocin infusion for induction of labor starting from 2 mIU/min, increasing it every 30 min with 2 mIU/min increments up to maximum of 40 mIU/min. The time from induction to delivery, the route of delivery, fetal outcome and maternal complications were recorded. Statistical analyses were performed using Mann-Whitney U-test, Chi-Square test and hypothesis test about differences for two proportions (t-test) to determine differences between the two groups. P < or = 0.05 was considered significant. RESULT: The mean time from induction to delivery was 9.91+/-4.30 and 10.88+/-4.72 h in the misoprostol and oxytocin administered group, respectively, with no significant difference between the groups. The rate of vaginal delivery was 84.4 and 87.5% in the misoprostol and oxytocin administered group, respectively, with no significant difference between the groups (P = 0.72). The rates of placental abruption and postpartum hemorrhage were similar in both groups and no case of uterine rupture occurred. The 1 and 5 min mean Apgar scores were 6.91+/-1.57-8.88+/-1.39 and 7.22+/-1.24-9.06+/-0.84 in the misoprostol and oxytocin administered group with no significant differences between the groups (P = 0.38 and 0.51). No case of asphyxia was present. The rate of admission to neonatal intensive care unit was higher in the misoprostol administered group, but the difference was not significant. CONCLUSION: Intravaginal misoprostol is an alternative method to oxytocin in induction of labor in great grandmultiparous pregnant women with low Bishop scores, as it is effective, cheap and easy to use. Safety about rare complications and neonatal morbidity needs clarifications with further studies.

Administration, Intravaginal↗

A comparison between two doses of intravaginal misoprostol and gemeprost for induction of second-trimester abortion.

OBJECTIVE: To compare the abortifacient efficacies of two intravaginally administered misoprostol doses and gemeprost in termination of second-trimester pregnancy. METHODS: Eighty-one women between 12 and 24 weeks' gestation requesting abortion were randomized to receive intravaginally either 100 micrograms of misoprostol at 6-hour intervals (n = 27), 200 micrograms of misoprostol at 12-hour intervals (n = 26), or 1.0 mg of gemeprost at 3-hour intervals (n = 28). The regimen was continued until abortion, or for 36 hours, with assessment of the rate of complete and incomplete abortions as well as side effects within 48 hours from the start of the treatment. RESULTS: The final rates of terminations were 74% in the 100-microgram misoprostol group, 92% in the 200-microgram misoprostol group, and 89% in the gemeprost group. Abortion was complete in 37%, 61%, and 32% in each group, respectively (P = .03, when the 200-microgram misoprostol group was compared with the two other groups). The induction-to-abortion interval was longer (P = .001) in the misoprostol groups (mean 23.1 hours for the 100-microgram and 27.8 hours for the 200-microgram dose) than in the gemeprost group (14.5 hours). There was less pain (P = .01), diarrhea (P = .001), and vomiting (P = .01) in the misoprostol groups than in the gemeprost group. The mean blood loss in the misoprostol groups was lower than in the gemeprost group (P = .001). CONCLUSION: Intravaginal application of 200 micrograms of misoprostol at 12-hour intervals in induction of second-trimester abortion is equally effective to a standard gemeprost regimen. Misoprostol causes fewer side effects and is cheaper and more practical to use.

Abortifacient Agents, Nonsteroidal↗

Treatment of vulvovaginal lichen planus with vaginal hydrocortisone suppositories.

OBJECTIVE: To estimate the effectiveness of vaginal hydrocortisone suppositories in the treatment of vulvovaginal lichen planus. METHODS: A nonprobability sample of 60 patients diagnosed with vulvovaginal lichen planus were treated with intravaginal hydrocortisone 25-mg suppositories (1-1/2) twice a day. The dose was tapered to two times a week dosing after several months to maintain symptom-free disease. The participants' charts were reviewed and pretreatment symptoms and physical examination were compared to posttreatment symptoms and physical examination. Data were analyzed using McNemar chi(2). RESULTS: The sample population included mostly white (86.7%) patients with a mean age of 58 years. Forty-three participants had complete data with follow-up subjectively and objectively after treatment. Most symptoms (eg, vulvar burning, pruritus, dyspareunia, vaginal discharge) were improved and the improvement was found to be statistically significant. Sexual activity was unchanged in the women. Additionally, most physical findings by examination (eg, erythema, erosions, vulvar and vaginal lesions) were improved and the improvement was found to be statistically significant. Vaginal stenosis did not significantly improve. Treatment was continued in 35 patients with a mean duration of 28.1 months. There was overall improvement in 81% subjectively and in 76.8% objectively. CONCLUSION: Intravaginal hydrocortisone suppositories are an effective treatment for vulvovaginal lichen planus.

Administration, Intravaginal↗

Development of an injection molded poly(epsilon-caprolactone) intravaginal insert for the delivery of progesterone to cattle.

This paper reports experiments conducted to research, develop and clinically evaluate an injection molded intravaginal insert manufactured from the biodegradable polyester poly(epsilon-caprolactone). The study demonstrated that it is possible to engineer poly(epsilon-caprolactone) into a shape that is well retained, and can be used as a platform for the controlled delivery of progesterone via the vagina of cows. Field evaluation showed that the poly(epsilon-caprolactone) intravaginal inserts containing 10% (w/w) progesterone were at least as effective clinically as the commercially available CIDR intravaginal insert.

Administration, Intravaginal↗

A prospective randomized study on oestradiol valerate supplementation in addition to intravaginal micronized progesterone in buserelin and HMG induced superovulation.

A prospective randomized study was conducted to evaluate the use of adding oestradiol valerate 6 mg per os daily to intravaginal micronized progesterone (600 mg daily) as luteal supplements. The study comprised 378 infertile women superovulated with a gonadotrophin releasing-hormone agonist (GnRHa) and human menopausal gonadotrophins (HMG) for in-vitro fertilization (IVF) or zygote intra-Fallopian transfer (ZIFT). The clinical pregnancy rate was similar (29%) whether or not oestradiol valerate was added to intravaginal progesterone. Eighteen out of twenty-two endometrial biopsies were in phase, and morphological evaluations of the two luteal supplementation groups were not different. Serum hormone profiles in singleton pregnancies showed a similar day of appearance of human chorionic gonadotrophin (HCG) in both protocols but significantly lower oestradiol concentrations arose in the group without oestradiol valerate. In 32% of the singleton pregnancies, the first appearance of HCG occurred later than day 12 after HCG injection; in those ongoing pregnancies, corpus luteum rescue--as measured by significantly lower serum oestradiol and progesterone concentrations--was compromised. This study provided no evidence of any benefit of routinely supplementing GnRHa/HMG cycles with oestradiol valerate in addition to intravaginal micronized progesterone.

Administration, Intravaginal↗

The use and physical effects of intravaginal substances in Zairian women.

Women in Kananga, Zaire, sometimes insert substances into the vagina to enhance sexual pleasure. The objective of this study was to ascertain: 1) what intravaginal substances are used, 2) the prevalence and frequency of their use, and 3) the visible effects they produce on the female genitalia. Focus group discussions with women and men were conducted, and both prostitutes and non-prostitutes were interviewed individually about their sexual preferences and practices. The cervices and vaginae of eight women were inspected and photographed before and after the insertion of commonly used substances. It was found that Kananga residents preferred a "dry-tight" vagina during coitus. They named thirty substances (leaves and powders) that women insert to produce this sensation. Twenty-one of 50 prostitutes (42%), and 17 of 49 non-prostitutes (35%), had used such intravaginal substances. Inspection of the genitalia showed that five different leaves produced inflammatory reactions that lasted up to a week. These genital irritations might facilitate the transmission of pathogenic organisms. Investigators elsewhere should study the use of intravaginal substances and their relationship to sexually transmitted diseases.

Administration, Intravaginal↗

Comparison of intracervical and intravaginal misoprostol for cervical ripening and labour induction in patients with an unfavourable cervix.

OBJECTIVE: To compare the efficacy of intracervical versus intravaginal misoprostol for cervical ripening and labour induction at term in patients with an unfavourable cervix. METHOD: A total of 100 pregnant women with indications for induction of labour and unfavourable cervix (Bishop score < or = 4) were randomly assigned to receive either 100 ug misoprostol administered intracervically (50 cases) or intravaginally (50 cases). RESULTS: No significant differences were noted between intracervical and intravaginal misoprostol in terms of Bishop score change, (score 7.2 vs score 7.5), interval from gel insertion to vaginal delivery (17.0 hours vs 16.4 hours), meperidine as analgesic requirement (80% vs 76%), route of delivery and perinatal outcome. Uterine tachysystole occurred in 24 per cent and 32 per cent in the intracervical and intravaginal groups respectively which did not significantly differ, however, all could be rapidly resolved by terbutaline injection. No evidence of fetal distress was noted in these events. Spillage of gel out of the cervix was observed in 70 per cent of patients receiving intracervical misoprostol. Fever was observed in one patient of each group. No other serious side effects were found in both groups. One patient in the intravaginal group had postpartum hemorrhage due to delayed placental separation and uterine atony. CONCLUSION: The two routes of misoprostol gel application appear to be safe and equally effective in ripening cervix and inducing labour, however, the intravaginal application is more convenient to administer practically compared with the intracervical.

Administration, Intravaginal↗

Misoprostol for uterine evacuation in patients with early pregnancy failures.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of misoprostol that is administered intravaginally for uterine evacuation in patients with early pregnancy failures. STUDY DESIGN: From March 2001 through March 2003, we treated 41 patients who had early pregnancy failures with vaginal misoprostol, 800 microg. A second course of misoprostol was administered if uterine evacuation did not occur in 24 hours. Patients who had no response to misoprostol underwent a surgical curettage. Our principal outcome measures were the percentage of patients who had successful evacuation of the products of conception and the frequency of adverse drug effects. RESULTS: Twenty-six patients had successful uterine evacuation with a single course of misoprostol; 6 patients required a second course. The overall success rate was 78% (95% CI, 63, 88). No patient experienced a serious adverse drug effect. CONCLUSION: Intravaginal misoprostol is a safe, effective alternative to surgical curettage for the treatment of early pregnancy failure.

Abortifacient Agents, Nonsteroidal↗

Vaginal misoprostol 1000 microg for early abortion.

The objective of this study was to evaluate the safety and efficacy of 1000 microg misoprostol vaginally (Cytotec) self-administered into the vagina for medical abortion. Three-hundred women with gestations between 42 and 63 days, with previous written consent, received vaginal misoprostol every 24 h up to a maximum of three doses for abortion. Outcome measures assessed included: successful abortion (complete abortion without surgery), side effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time of returning of menses. Complete abortion occurred in 279/300 (93.0%, 95% CI 90, 96) patients. Medication to relieve symptoms was administered to all subjects after every misoprostol dose. Vaginal bleeding lasted 14.7 +/- 5.4 days. Mean expulsion time was 8.1 +/- 3.0 h for those who aborted after the first misoprostol dose. The mean drop in hemoglobin was statistically significant (p = 0.0001) but without clinical relevance. The frequencies of nausea and diarrhea were high. According to the observed outcomes, 1000-microg misoprostol vaginally could be a valid method to terminate pregnancies up to nine weeks gestation.

Abortifacient Agents, Nonsteroidal↗

Induction of labor with vaginal misoprostol for second trimester termination of pregnancy in the scarred uterus.

OBJECTIVES: To assess the safety of vaginal misoprostol for second trimester pregnancy termination in patients with a history of cesarean section. METHODS: A consecutive series of 593 women with pregnancies of 14-26 weeks were studied. A cohort of 56 cases had undergone previous cesarean section delivery. The 528 cases who had no history of prior uterine surgery served as the controls. The termination was carried out according to the regimen used at the time of enrollment, either 600 microg applied at every 6 or every 12 h, or 800 microg applied at every 12 h using the vaginal route. RESULTS: The median induction to abortion time in the previous cesarean section group (15.1 h) was not significantly different from that of the controls (15.8 h). The median total dosage of misoprostol used was the same for both groups (1200 microg). The rates of incomplete abortion and analgesia usage were significantly higher in the previous cesarean section group as compared with the controls. CONCLUSIONS: Vaginal misoprostol was effective for the second trimester pregnancy termination but the safety of misoprostol in the scarred uterus cannot be assumed from this study. A large series is needed to reach the power to see the difference.

Abortifacient Agents, Nonsteroidal↗

Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets.

An open, randomized comparative clinical trial was performed in 153 patients suffering from symptomatic vaginal candidiasis confirmed by mycological tests. Patients were allocated at random into two groups: the first group (consisting of 75 subjects) was treated with a single vaginal ovule of fenticonazole (600 mg) and the second group (consisting of 78 subjects) was treated with a single vaginal tablet of clotrimazole (500 mg). Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days and 1 month (when possible) after the single dose treatment. At the first follow-up visit, complete disappearance of the signs and symptoms or a highly significant reduction of their intensity was observed in both treatment groups. No significant difference was evident between the two drugs. At 7 days, the mycological tests gave negative results in 92% of the patients in the fenticonazole group and in 88.5% of the patients in the clotrimazole group. The difference between the two treatment groups was again not statistically significant. The second follow-up visit was performed in 55 (73.3%) patients of the fenticonazole group and in 52 (66.7%) patients of the clotrimazole group. The results indicate that 83.6% of patients in the fenticonazole group and 69.2% of patients in the clotrimazole group were still disease free at the time of this visit. Both drugs were well tolerated. Mild, local and short lasting side-effects were reported in only 5 cases of the group treated with fenticonazole.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗