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PubMed2003

Spermicidal activity of the crude ethanol extract of Sedum praealtum in mice.

Ethanol extract of Sedum praealtum in intravaginal doses of 10, 20, 40, 50, 100 and 150 mg/kg body weight showed a toxic effect in spermatozoa viability after 24h of administration. Spermatozoa viability was 94, 83, 58 and 24%, respectively, for extract doses of 10, 20, 40 and 50mg/kg body weight, while only dead spermatozoa were found in the vagina of the treated female mice with doses of 100 and 150 mg/kg body weight.

Administration, Intravaginal↗
PubMed2004

EDTA-induced activation of Ca-regulated proteins in the vaginal mucosa.

The effects of EDTA on the expression and topologic localization of mitogen-activated protein (MAP) kinases (ERK, JNK, and p38), along with nitric oxide synthase (NOS), I-KappaB, and p53 were examined to elucidate the host response provoked by the intravaginal application of a female controlled drug delivery system (FcDDS) containing a spermicidal/microbicidal agent and EDTA. Immunohistochemical and immunoblotting studies were conducted to identify and quantitate the EDTA-inducible proteins in vaginal mucosa. The content of nitrite, which is one of the primary stable breakdown products of nitric oxide (NO), was determined to correlate the expression of NOS with NO formation in HeLa cervical carcinoma cell line. The immunohistochemical study demonstrated that the modulation of the calcium gradient by EDTA activated MAP kinases (ERK and JNK) in the rabbit vaginal mucosa. The results of Western immunoblot study demonstrated differential expression of MAP kinases (ERK and JNK) with EDTA treatment, whereas the expression of NOS and NF-KappaB was not affected by EDTA. There was no significant difference in nitrite production in the HeLa cell line upon exposure to EDTA compared with the control, which was consistent with the results of the Western blot study. The results of this work support that the regulation of MAP kinase was affected by calcium, which is controlled by chelation activity of EDTA. The specific tissue responses exerted by the loading components of a biomaterial-based system should be fully taken into consideration for its intravaginal application.

Administration, Intravaginal↗
PubMed1994

Bacterial vaginosis: efficacy and safety of intravaginal metronidazole treatment.

OBJECTIVE: We evaluated the effectiveness and safety of intravaginal metronidazole in the treatment of bacterial vaginosis. Demographic data, Gram stain score, and individual clinical diagnostic criteria for bacterial vaginosis were evaluated for association with therapeutic outcome. METHODS: According to accepted diagnostic criteria and blinded Gram stain scoring for quality control, a multicenter, prospective, double-blinded trial of patients randomized to either 0.75% metronidazole gel 5 gm twice daily for 5 days or placebo was undertaken. Therapeutic response after completion of treatment was evaluated by examination at 4 to 16 days and again at 28 to 32 days for patients initially cured. RESULTS: After metronidazole treatment, 38 (78%) of 49 patients were cured initially, compared with 11 (27%) of 41 placebo recipients (p < 0.001). One month after treatment 31 (91%) of 34 in the group initially cured by metronidazole remained cured. Side effects were uncommon and mild. Significant intercenter differences were noted for vaginal discharge assessment but not for other diagnostic criteria. Among patients cured initially with metronidazole, mean Gram stain score was 0.58 among those in whom cure was maintained versus 2.33 for those in whom recurrent bacterial vaginosis developed 1 month after treatment (p = 0.03). Curative metronidazole treatment was found initially in 4 (100%) of 4 patients with sperm present on gram stain compared with 34 (76%) of 45 with sperm absent (p = 0.56) and in 6 (100%) of 6 and 25 (89%) of 28, respectively, at the final visit (p = 1.0). CONCLUSIONS: Intravaginal metronidazole is effective, safe, well-tolerated, durable therapy for bacterial vaginosis. Characterization of vaginal discharge appears to be the most variable among the diagnostic criteria for bacterial vaginosis. Gram stain score may be able to identify patients cured early after therapy who are at risk for later recurrence. Exposure to semen does not appear to affect efficacy of intravaginal metronidazole.

Administration, Intravaginal↗
PubMed2002

Prostaglandin E2 gel versus misoprostol for cervical ripening in patients with premature rupture of membranes after 34 weeks.

OBJECTIVE: To compare intravaginal misoprostol to prostaglandin (PG) E2 for cervical ripening in women with premature rupture of the membranes (PROM) after 34 weeks of gestation. METHODS: Women with PROM after 34 weeks of gestation and an unripe cervix were randomized to receive PGE2 (2.5 mg) or misoprostol (50 microg). Both agents were placed intravaginally immediately after randomization, and the dose was repeated 6 hours later if necessary. After another 6 hours from the second insertion, oxytocin treatment was started if labor had not begun. Forty patients in each group were required to show a 30% improvement in delivery within 12 hours in the misoprostol group. RESULTS: One hundred nine patients were randomized; 54 were assigned to misoprostol and 55 to PGE2. Important demographic and clinical characteristics were similar between the groups. The mean time from first insertion to delivery was 16.4 hours in the misoprostol group and 22.0 hours in the PGE2 group. A second dose was required less frequently in the misoprostol group (22% vs 62% in the PGE2 group), and the percentage of patients delivered within 12 hours was higher in the misoprostol group (41% vs 16%). Tachysystole occurred in 20% and 6% of women in the misoprostol and PGE2 groups, respectively. Hyperstimulation occurred in 9% and 0%, and cesarean delivery in 19% and 26% of women in the misoprostol and PGE2 groups, respectively. Neonatal outcome was similar between groups. CONCLUSION: Intravaginal misoprostol is more effective than local PGE2 application to treat PROM after 34 weeks of gestation, but tachysystole occurs more commonly with misoprostol.

Administration, Intravaginal↗
PubMed2004

A randomised trial comparing low dose vaginal misoprostol and dinoprostone for labour induction.

OBJECTIVE: To compare vaginal misoprostol with dinoprostone for induction of labour. DESIGN: Randomised multicentre trial. SETTING: Labour wards of one university hospital and two teaching hospitals. POPULATION: Six hundred and eighty-one women with indication for labour induction at >or=36 weeks of gestation, singleton pregnancy and no previous ceasarean section. METHODS: Misoprostol (25 mcg, hospital-prepared capsule) in the posterior vaginal fornix, every four hours, maximum three times daily or dinoprostone gel (1 mg) every four hours. Oxytocin was administered if necessary. MAIN OUTCOME MEASURES: Primary: 'adverse neonatal outcome' (5-minute Apgar score <7 and/or umbilical cord pH <7.15). Secondary: labour duration, mode of delivery and patient satisfaction. RESULTS: Three hundred and forty-one women received misoprostol and 340 dinoprostone. The median induction-delivery interval was longer in the misoprostol group compared with the dinoprostone group (25 versus 19 hours, P= 0.008). The caesarean section rate was lower in the misoprostol group: 16.1%versus 21%, but this difference was not statistically significant RR = 0.8 (95% CI 0.6-1.04). 'Adverse neonatal outcome' was found to be similar in both groups: 21% in the misoprostol and 23% in the dinoprostone groups. Significantly fewer neonates were admitted to NICU in the misoprostol group compared with dinoprostone 19%versus 26% (RR = 0.7, 95% CI 0.5-0.98). CONCLUSIONS: Misoprostol in this dosing regimen is a safe method of labour induction. NICU admission rates were lower in the misoprostol group. No difference could be detected in patient satisfaction between groups.

Administration, Intravaginal↗
PubMedDate not supplied

Induction of candidal vaginitis in diabetic mice and attempts to prevent the infection.

In the present study on the induction and prevention of candidal vaginal infection in diabetic mice, ICR female mice were rendered diabetic by intraperitoneal injections of 160 mg kg-1 streptozotocin (SZ) which induced a stable non-lethal diabetic state apparent 2-7 days post-SZ injection. Diabetic mice and non-diabetic controls were inoculated intravaginally with 10(7)-10(10) Candida albicans yeasts. Infection was evaluated by the number of infected mice 3 days post-inoculation and the rate of clearance of infection during a 35-day follow-up. All C. albicans doses investigated induced vaginal infection in the diabetic mice, while in the non-diabetic controls only 40% of those inoculated with the lower (10(7) CFU) dose developed infection. The yeast load in the diabetic mice was 10-fold higher than in the controls and the duration of infection was longer. In an attempt to prevent infection intravaginal treatment with 5-40 mg of a chitin derivative (CSE) mouse-1 was given prior and pre- and post-inoculation with C. albicans. The optimal CSE treatment regimen was both pre- and post-administration of 10 or 20 mg CSE mouse-1 which significantly reduced the number of infected animals and also the duration of infection.

Administration, Intravaginal↗
PubMed2000

Management of intravaginal warts in women with 5-fluorouracil (1%) in vaginal hydrophilic gel: a placebo-controlled double-blind study.

The purpose of this placebo-controlled, double-blind study was to determine the safety, tolerability and clinical efficacy of 5-fluorouracil (1%) in a vaginal hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal papillomas in women. Pre-selected, 60 women ranging between 18 and 50 years of age (mean 24.6), having 312 vaginal condylomas (mean 5.2) joined the study. The diagnosis of human papillomavirus (HPV) was established with clinical, histopathological and polymerase chain reaction (PCR) techniques. Subjects were randomized into 2 parallel groups. Each patient was allocated a pre-coded tube 15 g (active or placebo) with graduated vaginal applicators (disposable), and instructions how to insert 4 g of the trial medication deep into the vagina once at bedtime on every other day (1, 3 and 5) per week, to visit the clinic on day 7 for clinical evaluations and to receive the same pre-coded replacement to continue the regimen for another week. A maximum 12 applications were to be used in 4 weeks. Cure was defined as absence of clinical signs of infection, re-confirmed by PCR and Southern blot hybridization negative HPV DNA. By the end of the treatment 48.4% patients and 51.9% lesions were cured. Breaking the code revealed that 5-fluorouracil (1%) gel had cured 83.3% patients and 87% intravaginal warts. Placebo resolved 13.3% patients and 14% condylomas; (active gel versus placebo; P < 0.001). Twelve patients (20%) mostly in the active gel experienced mild erythema, erosion and oedema, with no drop-outs. Among cured patients 3 had a relapse after 16 months. In conclusion, the clinical results of the study demonstrate that 5-fluorouracil (1%) in a vaginal hydrophilic gel is safe, tolerable and significantly more effective than placebo to cure intravaginal warts in women.

Administration, Intravaginal↗
PubMed1997

The use of misoprostol for abortion at < or = 9 weeks' gestation.

OBJECTIVE: To verify the efficacy and safety of misoprostol for abortion at < or = 63 days' gestation. METHOD: A total of 175 women seeking elective abortion at < or = 63 days' gestation received 800 micrograms of misoprostol vaginally. This dose was repeated at 48 and 96 h if abortion did not occur. Afterwards, up to three additional 600- or 400-micrograms doses of misoprostol were administered if the uterus was not empty, as judged by ultrasound. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), side-effects and vaginal bleeding. RESULTS: Complete abortion occurred in 161/175 (92.0%; 95% CI 87-96%) subjects and 14/175 (8.0%; 95% CI 4-13%) cases failed. The immediate success rate was 77.7% with the first dose, 13.7% with the second dose and 0.6% with the third dose. The decrease in hemoglobin was statistically significant (p = 0.009) but without clinical relevance; before treatment: 11.94 mg/dl (SD 1.60) and after treatment: 11.64 mg/dl (SD 1.08). No significant differences were obtained between success rates and failures in relation to age, gravidity, parity, previous abortions, race, gestational age and side-effects. The third main dose of misoprostol showed very little efficacy. Vaginal bleeding lasted 5.5 +/- 2.8 days, spotting 5.7 +/- 3.1 days and total bleeding 11.2 +/- 3.0 days. CONCLUSIONS: The success percentage attained shows that 800 micrograms of misoprostol administered vaginally effectively causes abortion at < or = 63 days' gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

[Incidence of inflammatory placental changes in threatened premature labor with and without additional antibiotic therapy].

Considering the causal association of silent intrauterine infection and prematurity we investigated the possible effect of adjuvant antibiotic treatment of women with preterm labour on the appearance of inflammatory placental lesions. 140 patients with preterm labour in the 30 + 2 week of gestation (median; range: 17 + 2-34 + 6) without premature rupture of the membranes and detection of facultative-pathogenic micro-organisms in the vagina and/or in the canal of the cervix were enrolled in the study. 74 women were treated vaginally (polyvidone-iodine) in addition to intravenous tocolysis, 66 women were given ampicillin, cefotiam or erythromycin intravenously. After delivery the placentas were examined histologically and the frequency of inflammatory lesions was evaluated by use of 4 scores of classification. For statistical analysis the Fisher Exact- and the Wilcoxon Rank Sum Test were used. We found no differences concerning amnamnestic and perinatal parameters comparing the 2 groups of patients. With only one of the histological scores used (according to Salafia et al. [18]) we found a higher frequency of inflammatory placental lesion in the antibiotic treated group (12/66) in comparison to the vaginal treated group (4/74). Fifty patients of the antibiotics' group received the antibiotic during the last 10 days before birth. No differences in the frequency of inflammatory placental lesions were detectable in these patients when compared with the local treated group. However, we found a lower prolongation of gestation (calculated from the day of admission to the day of delivery, median: 7; range: 1-92 days) and a lower gestational age at delivery (median: 33 + 0; range: 22 + 2-39 + 6 weeks) in the patients receiving antibiotics during the last 10 days before birth in comparison to the local treated women (22; 1-138 days and 35 + 0; 23 + 4-41 + 5 weeks, respectively). There is the same incidence of inflammatory placental lesions in patients with preterm labour and facultative-pathogenic micro-organisms in the vagina and/or in the canal of the cervix who received adjuvant antibiotic treatment during pregnancy compared with patients who were treated vaginally with polyvidone-iodine.

Administration, Intravaginal↗
PubMed2004

Efficacy of nonhormonal vaginal contraceptives from a hydrogel delivery system.

This investigation describes the synthesis of a biodegradable hydrogel composed of a core surrounded by four concentric sheaths containing dextran, copolymers of polylactide and epsilon-caprolactone. The hydrogel was impregnated with iron (II) d-gluconate dihydrate, which causes complete spermiostasis due to lipid peroxidation, ascorbic acid to increase the viscosity of the cervical mucus and mixtures of polyamino and polycarboxylic acids to sustain vaginal pH close to 4.5. The combined effects of the agents in the daily eluates of the hydrogel were efficacious up to 16 days, within 30 s, as shown by sperm penetration tests. For in vivo studies, rabbits were chosen as the experimental model because they are easy to handle and the female is always in estrus. The anterior vagina of estrous female rabbits was instilled with the hydrogel, and then inseminated with the semen from a fertile male. Postinsemination flush from the female rabbits showed that all of the sperm were dead. These observations demonstrate the potential for the development of a biocompatible, nonhormonal, intravaginal contraceptive device.

Administration, Intravaginal↗
PubMed1999

Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring.

A study was performed to establish the tolerance, acceptability and associated efficacy of a levonorgestrel-releasing intravaginal ring (IVR) in a sample of British women requiring contraception. This was achieved with an open non-randomized prospective study of 1710 women aged 18-40 years, recruited in 75 centers geographically spread around the UK using an IVR designed to release 20 microg/day of levonorgestrel. Assessments were made at baseline, after 6 weeks, after 3 months and then 3-monthly. After initial insertion of the IVR, it was changed at 3-monthly intervals. A total of 1591 women were eligible for analysis, with 572 available after 12 months and 34 after 24 months of use. Life-table analysis revealed pregnancy rates of 5.1% and 6.5% at 12 months and 24 months, respectively. The IVR was rated as acceptable or very acceptable as a form of contraceptive by 60.7% of women at 12 months. The most common adverse events were menstrual disturbance, headache and vaginal discharge. No significant pattern of biochemical, hematological, microbiological or cytological abnormalities was found but vaginal erythematous lesions were noted at some centers. This IVR was found to be a generally well-accepted method of contraception with a failure rate comparable to some other progestogenonly methods. On this basis, further development of hormone-releasing intravaginal rings is justified.

Administration, Intravaginal↗
PubMed2001

[Application of 2% clindamycin cream in the treatment of bacterial vaginosis and valuation of methylcellulose gel containing the complex of Chitosan F and PVP k-90 with lactic acid as carrier for intravaginally adhbited medicines in the cases of pregnancies with the symptoms of preterm delivery].

OBJECTIVES: There are many reports informing about the connection between BV and the increased risk of preterm delivery. The reason of self-concession and reversion of BV after having executed an efficient treatment has not yet been properly explained. DESIGN: The aim of this work was the clinical valuation of the 2% Clindamycin cream in the treatment of BV and of the methylcellulose gel containing the complex of Chitosan F and PVP K-90 with lactic acid as a carrier for intravaginally adhbited medicines in the cases of pregnancies with the symptoms of a preterm delivery. MATERIAL AND METHODS: The research comprised 145 pregnant between 24-34 week of pregnancy, hospitalised because of the symptoms of a preterm menace delivery. In the case of the detection of BV, a 10-day therapy using intravaginal cream containing 2% Clindamycin was executed. In the cases not qualified as BV, the methylcellulose gel containing the complex of Chitosan F and PVP K-90 with lactic acid has been intravaginally adhibited for 10 days. CONCLUSIONS: 1. Application of 2% Clindamycin cream is an efficient method of the treatment of bacterial vaginosis. 2. Methylcellulose gel containing lactic acid combined with the complex of Chitosan F and PVP K-90 allows a persistent maintenance of the correct pH of vagina. 3. Methylcellulose gel, because of its physico-chemical properties similar to physiological mucus, is a universal carrier for intravaginally adhibited medicines.

Administration, Intravaginal↗
PubMed2003

The efficacy of vaginal clindamycin for the treatment of abnormal genital tract flora in pregnancy.

OBJECTIVE: To assess the efficacy of 2% clindamycin vaginal cream (CVC) to treat bacterial vaginosis (BV) in pregnancy. METHODS: A prospective, randomized, double-blind, placebo-controlled, tricenter study. Four hundred and four women with BV on Gram stain at their first antenatal clinic visit were randomized to receive a 3-day course of 2% CVC or placebo. The outcome was assessed using an intention to treat analysis at 3 weeks and 6 weeks post-treatment according to three different diagnostic methods based on five criteria (Gram stain and all four elements of clinical composite criteria: vaginal discharge, abnormal vaginal pH, clue cells, amine odor), three criteria (vaginal pH, clue cells, amine odor) or two criteria (clue cells and amine odor) to reflect stringency of diagnosis, historical precedence and government agency recommendations respectively. RESULTS: Using five diagnostic criteria, 18% of CVC patients were cured and 70.8% either cured and/or improved compared to 1.6% and 12% of placebo patients respectively (p < 0.0001). Using three diagnostic criteria, 44.8% of CVC patients were cured and 77.3% were either cured and/or improved compared to 9.3% and 28.8% of placebo patients respectively (p < 0.000 1). Using two diagnostic criteria, 75.0% of CVC patients were cured compared to 18.0% of placebo patients (p < 0.0001 ). Recurrence rates in those CVC patients successfully treated were approximately 6% at 6 weeks post baseline and 10% at 28 to 34 weeks gestation. CONCLUSIONS: A 3-day course of CVC appears to be well tolerated by the mother and statistically significantly more efficacious than placebo in the treatment of BV during the second trimester of pregnancy.

Administration, Intravaginal↗
PubMed2000

Misoprostol for abortion up to 9 weeks' gestation in adolescents.

The objectives of the present clinical study were to evaluate the safety and efficacy of misoprostol (Cytotec) self-administered into the vagina for medical abortion in adolescents under the age of 18 years. After obtaining written consent from the patients and parents or guardians, a group of 150 adolescents with gestations between 35 and 63 days received 800 microg of vaginal misoprostol every 24 h, up to a maximum of three main doses, for abortion. Outcomes assessed included successful abortion (complete abortion without surgery), side-effects, decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time for the return of menses. Complete abortion occurred in 133/150 (88.7%, 95% confidence interval 82-93) patients. The frequencies of nausea, vomiting and diarrhea were statistically significantly higher when compared to those obtained for adult females. Vaginal bleeding lasted for 12.7 +/- 5.7 days (median 12 days, range 1-23 days). The mean expulsion time was 6.8 +/- 2.4 h (median 6 h, range 3-14 h) for those who aborted after the first misoprostol dose. The mean time for the return of menses, for those who aborted with misoprostol, was 34.7 +/- 3.4 days. The mean decrease in hemoglobin was statistically significant (p = 0.001), but had no clinical relevance. Taking into account the high abortion rate obtained, we could conclude that misoprostol alone is a valid method for terminating unwanted pregnancies in adolescents under the age of 18 years.

Abortifacient Agents, Nonsteroidal↗