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PubMed2004

Preclinical evaluation of magainin-A as a contraceptive antimicrobial agent.

OBJECTIVE: To evaluate the safety and contraceptive efficacy of magainin-A in monkeys. DESIGN: Controlled laboratory study. SETTING: Department of Immunology, National Institute for Research in Reproductive Health, Parel, Mumbai, India. ANIMAL(S): Male and female bonnet monkeys (Macaca radiata). INTERVENTION(S): Animals were treated intravaginally with 1 mg of magainin-A before attempted conception, as well as daily for 14 days to assess local and systemic toxicity. MAIN OUTCOME MEASURE(S): Suitability of magainin-A for the control of pregnancy and sexually transmitted infections. RESULT(S): Complete sperm immobilization was observed within 20 seconds after the exposure to magainin-A (800-1,000 microg) in vitro. Intravaginal administration of 1 mg of magainin-A blocked conception in monkeys. When magainin-A was administered intravaginally for 14 consecutive days, no treatment-related abnormalities were observed in menstrual cycle length, vaginal epithelial cell morphology, and hematologic/serum biochemical profiles. The peptide inhibited the growth of sexually transmitted infection-causing pathogens but not HIV-1 and HIV-2. CONCLUSION(S): Magainin-A can be used as an effective and safe intravaginal contraceptive compound with additional protection against sexually transmitted infection-causing pathogens.

Animals↗
PubMedDate not supplied

[Comparative evaluation of chronic estrone toxicity when administered by different routes].

The paper concerns the results of studying chronic toxicity of estrone injected subcutaneously in the form of oily solution and vaginal suppositoria prepared on the basis of vitepsol. It has been shown that subcutaneous administration of the drug for 2 months results in dystrophic alterations in the liver, these alterations being more pronounced than those induced by intravaginal administration of estrone in the form of suppositoria.

Animals↗
PubMed2004

Effect of lactobacilli administration in the vaginal tract of mice: evaluation of side effects and local immune response by local administration of selected strains.

Lactobacilli are the predominant microorganisms in the vaginal tract of human and some homeothermic animals. They can maintain the ecological equilibrium of the tract by protecting against pathogenic microorganisms. In the last few years, there has been an increased tendency to use probiotic microorganisms to restore the ecological equilibrium and to protect against infections. This principle has been widely applied to the gastrointestinal tract. More recently, some other studies have reported the application of probiotics in different tracts, for example, the urogenital or respiratory tract. One of the objectives of our group is to design probiotic products for the urogenital tract. With this purpose, lactobacilli were isolated from the human vagina, and later some of them were selected for their probiotic characteristics (production of antagonistic substances or adhesion capability). The application of probiotic products in the vaginal tract has been approached empirically; some pharmaceuticals containing these microorganisms are available in the United States or Europe or are protected under the patent process or intellectual property rights. There are not enough studies in humans or animals to determine whether their administration can produce some type of collateral or adverse effect. Using Balb/c mice as the experimental model, the object of the present work was to study (1) whether intravaginal administration of human lactobacilli can produce colonization of the tract; (2) whether such administration produces some type of adverse or collateral effect; and (3) whether probiotics are able to stimulate the local immune system. Keeping in mind that hormones can affect the colonization or persistence ability of microorganisms, and with the purpose of having all animals at the same point in the sexual cycle, animals were cycled with estradiol 48 h before inoculation with lactobacilli. They were then inoculated im with hormones 48 h before beginning microorganism inoculations. Later they were intravaginally inoculated with the appropriate dose of each Lactobacillus strains. The animals were sacrificed on different days after inoculation to perform the following studies: 1. Microbiological assays: To determine the number of lactobacilli in the tract (in vaginal washes or in organ homogenates), by plating the samples in selective media containing antibiotic (to differentiate the resident flora from those administered experimentally).

Animals↗
PubMed2001

Contraceptive efficacy and safety studies of a novel microemulsion-based lipophilic vaginal spermicide.

OBJECTIVE: To investigate the in vivo contraceptive potency and safety of a novel microemulsion-based lipophilic vaginal spermicide. DESIGN: In vitro and in vivo spermicidal activity and safety of a submicron-particle-size, lipophilic gel-microemulsion (GM-4). SETTING: Center for Advanced Preclinical Sciences at the Parker Hughes Institute. PATIENT(S): Nine male volunteer sperm donors. INTERVENTION(S): Motile human sperm in semen and medium were exposed to eight GM-4 components or GM-4 formulation. Forty-eight ovulated NZW rabbits in subgroups of 16 with or without intravaginal administration of GM-4 or nonoxynol-9 gel (N-9; Gynol II) were artificially inseminated and allowed to complete pregnancy. Eleven rabbits were exposed to daily intravaginal application of GM-4 with and without N-9 for 10 consecutive days. Ten of 20 B(6)C(3)F(1) mice were given repetitive intravaginal application of GM-4 for 5 days/week over 13 consecutive weeks. MAIN OUTCOME MEASURE(S): The motility of human sperm treated with GM-4 components and GM-4. Term pregnancy in rabbits and histopathological grading of rabbit vaginal tissue for irritation. Evaluation of mice for survival, growth, hematologic parameters, blood-chemistry profiles, absolute and relative organ weights, and histopathology. RESULT(S): The individual components of GM-4 lacked spermicidal activity in human semen, whereas the GM-4 formulation containing all the eight pharmacological excipients exhibited potent spermicidal activity with rapid kinetics. GM-4 showed remarkable contraceptive activity in the rigorous rabbit model. None of the 16 (0%) rabbits given GM-4 intravaginally before artificial insemination became pregnant. By contrast, 15 of 16 (93.7%) control rabbits and 5 of 16 (31.2%) Gynol II-treated rabbits became pregnant and delivered newborns. Thus, GM-4 was a significantly more effective contraceptive than a commercially available N-9 gel [100% vs. 68.7% protection; P< 0.05, Fisher's exact test]. Unlike the rabbits treated with N-9, none of the rabbits that were given GM-4 intravaginally for 10 consecutive days developed epithelial ulceration, edema, leukocyte influx, or vascular congestion characteristic of inflammation. Furthermore, repeated intravaginal application of GM-4 for up to 13 weeks in mice had no adverse effects on survival, growth, metabolism, or organ function. CONCLUSION: We conclude that the novel spermicidal GM-4 formulation is safe and significantly more effective than N-9 in preventing conception.

Animals↗
PubMed2006

Mucosal administration of CpG oligodeoxynucleotide elicits strong CC and CXC chemokine responses in the vagina and serves as a potent Th1-tilting adjuvant for recombinant gD2 protein vaccination against genital herpes.

Although sexually transmitted pathogens are capable of inducing pathogen-specific immune responses, vaginal administration of nonreplicating antigens elicits only weak, nondisseminating immune responses. The present study was undertaken to examine the potential of CpG-containing oligodeoxynucleotide (CpG ODN) for induction of chemokine responses in the genital tract mucosa and also as a vaginal adjuvant in combination with glycoprotein D of herpes simplex virus type 2 (HSV-2) for induction of antigen-specific immune responses. We found that a single intravaginal administration of CpG ODN in mice stimulates a rapid and potent response of CC chemokines macrophage inflammatory protein 1alpha (MIP-1alpha), MIP-1beta, and RANTES as well as of CXC chemokines MIP-2 and IP-10 in the vagina and/or the genital lymph nodes. Importantly, intravaginal vaccination with recombinant gD2 in combination with CpG ODN gave rise to a strong antigen-specific Th1-like immune response in the genital lymph nodes as well as the spleens of the vaccinated mice. Further, such an immunization scheme conferred both systemic and mucosal immunoglobulin G antibody responses as well as protection against an otherwise lethal vaginal challenge with HSV-2. These results illustrate the potential of CpG ODN for induction of potent chemokine responses in the genital tract and also as a vaginal adjuvant for generation of Th1-type mucosal and systemic immune responses towards a nonreplicating antigen derived from a sexually transmitted pathogen. These data have implications for the development of a mucosal vaccine against genital herpes and possibly other sexually transmitted diseases.

Adjuvants, Immunologic↗
PubMed1999

Comparison of once-daily and twice-daily dosing of 0.75% metronidazole gel in the treatment of bacterial vaginosis.

BACKGROUND AND OBJECTIVES: Bacterial vaginosis is the most common cause of vaginal symptoms in women and has potential complications. Efforts to improve treatment of this disease process are warranted. GOAL OF THIS STUDY: The goal of this study was to compare the safety and efficacy of once-daily intravaginal administration of 0.75% metronidazole gel for 5 days to the established twice-daily regimen in the treatment of bacterial vaginosis. STUDY DESIGN: Nonpregnant women with bacterial vaginosis diagnosed by accepted clinical criteria at 14 geographically diverse general gynecology clinics were enrolled in this prospective, randomized, investigator-blind, parallel study. They were treated with either once-daily or twice-daily 0.75% metronidazole gel 5 g intravaginally for 5 days and were reevaluated at 7 to 12 days and 28 to 35 days after completing treatment. Efficacy was determined by clinical criteria. Adverse drug reactions were monitored. RESULTS: Of the 514 evaluable women enrolled, bacterial vaginosis was cured at the first return visit among evaluable patients in 153 of 199 (77%) of those who received the once-daily and in 157 of 196 (80%) of those who received the twice-daily administration. Bacterial vaginosis was cured among evaluable patients at the final visit in 104 of 180 (58%) of those who received once-daily and 109 of 178 (61%) of those who received the twice-daily regimen. Intent-to-treat analysis showed cure at 1 month in 118 of 207 (57%) of those treated once daily and 129 of 209 (62%) of those treated twice daily. Side effects were mild, and none caused treatment discontinuation. CONCLUSIONS: Once-daily dosing of 0.75% metronidazole gel 5 g for 5 days yields efficacy, safety, and tolerance equivalent to the currently used twice-daily dosing in the treatment of bacterial vaginosis, adding another competitive choice to the available therapeutic options for this condition.

Adult↗
PubMed1980

Studies on Nonoxynol-9. II. Intravaginal absorption, distribution, metabolism and excretion in rats and rabbits.

Some pharmacological aspects of Igepal CO-630, used by some pharmaceutical companies as the source of nonylphenoxypoly (ethyleneoxy) ethanol (Nonoxynol-9, N-9) in various spermicidal formulations, were studied. It was found that Igepal CO-630 contains at least 13 components, 70% having molecular weights near that of N-9. After intravaginal administration, the detergent is rapidly and quantitatively absorbed through the vaginal wall into the systemic circulation. The rate of vaginal absorption of N-9 depends on the vehicle in which the detergent is carried. Once in the blood, N-9 is excreted by liver-bile-feces and the kidney-urine routes, the first being more effective in rats, the latter in rabbits. Following intravaginal or intraperitoneal injection of radioactive N-9, the highest content of radioactivity was found in the liver and kidney. The detergent was detected in the milk of lactating rats and the serum of their pups within two hours after the intravaginal dose.

Absorption↗
PubMed1976

Corpus luteum function in the ewe: effect of PGF2alpha and prostaglandin synthetase inhibitors.

A series of experiments were conducted to evaluate the effects of mode and frequency of administration and estrous cycle stage on the response of the cycling ewe to PGF2alpha. The effects of dexamethasone, arachadonic acid and prostaglandin synthetase inhibitors on estrous cycle length and plasma progesterone levels were also determined. Intramuscular administration of 5 or 10 mg of PGF2alpha, on days 8 and 9 after estrus (5 ewes/group), significantly (p less than .01) shortened the mean length of the estrous cycle and the interval from the end of treatment to estrus. Mean plasma progesterone levels, 24 hours after initial injection, were significantly (p less than .01) lowered. When administered on day 8 only, these doses were considerably less effective in shortening estrous cycle length or lowering plasma progesterone levels. Intravaginal administration of PGF2alpha, by polyurethane tampon, was also largely ineffective. Treatment of ewes with 10 mg of PGF2alpha, by polyurethanetampon, was also largely ineffective. Treatment of ewes with 10 mg of PGF2alpha i.m., on days 3 and 4 of the estrous cycle, resulted in a return to estrus in 2 days in 25% of the treated animals. Plasma progesterone levels of PGF2alpha-treated ewes were significantly lower than controls on the second, third and fourth days after the start of dosing. It would appear that PGF2alpha exerts a retarding effect on developing CL functionality. The prostaglandin synthetase inhibitors, aspirin, flufenamic acid and 1-p-chlorobenzylidene-2-methyl-5-methoxy-3-indenylacetic acid, were administered orally or parenterally for 16 days beginning on day 8 of the estrous cycle. These compounds failed to prolong estrous cycle length. Parenteral administration of dexamethasone did not result in PGF2alpha release in the cycling ewe, at least not in quantities sufficient to induce luteolytis. The prostaglandin precursor, arachadonic acid, also was not luteolytic when given parenterally to cycling ewes.

Acetates↗
PubMed2005

A comparison of oral misoprostol tablets and vaginal prostaglandin E2 pessary in induction of labour at term.

OBJECTIVE: To compare the cost-effectiveness, mode of delivery, fetal and maternal outcome of oral Misoprostol and vaginal prostaglandin E2 pessary in induction of labour at term. DESIGN: Randomized clinical trial. PLACE AND DURATION OF STUDY: Hamdard University Hospital, Imam Clinic and General Hospital from February 2002 to January 2003. PATIENTS AND METHODS: The trial was conducted over two groups of patient for labour induction such that Group A received 50 microg oral Misoprostol 4 hourly to a maximum of four doses. Group B received prostaglandin E2 vaginal pessary at 6 hourly intervals upto two doses. Labour induction, number of doses, need of augmentation, induction to delivery time interval, mode of delivery and neonatal outcome were the main outcomes. Test of proportions was used to compare the significance between both managements. RESULTS: Out of a total of 214 women, 106 received oral Misoprostol and 108 received PGE2 vaginal pessary. Ninety-three percent women in misoprostol group were successfully induced compared with 91% in PGE2 group. A significant response of labour induction with the minimal dose (58%, p = 0.001) and earlier induction to vaginal delivery (74%, p = 0.01) was observed in Misoprostol group. Rate of operative delivery was also less (16%, p = 0.16) compared with PGE2 group (25%). CONCLUSION: Oral Misoprostol administration was more efficient and cost-effective than PGE2 vaginal pessary for induction of labour due to earlier response with minimal dose and less number of operative deliveries.

Administration, Intravaginal↗
PubMed2000

Oral misoprostol for induction of labour with a viable fetus.

BACKGROUND: Misoprostol is a synthetic prostaglandin which has been used to induce labour. Oral use of the drug misoprostol may be convenient, but an overdose could cause uterine hyperstimulation and precipitate labour which may be life-threatening for both mother and fetus. OBJECTIVES: The objective of this review was to assess the effects of oral misoprostol used for labour induction in women with a viable fetus. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. SELECTION CRITERIA: Randomised trials of oral misoprostol versus any other method, placebo or no treatment given to women with a viable fetus for induction of labour. DATA COLLECTION AND ANALYSIS: The selection of trials and data extraction were undertaken by one reviewer and independently checked by two other reviewers. MAIN RESULTS: Five trials were included. In one placebo trial, oral misoprostol reduced the need for oxytocin infusion and shortened delivery time in women with prelabour rupture of membranes at term. In another trial, compared to vaginal prostaglandins, oral misoprostol reduced the need for oxytocin (relative risk 0.62, 95% confidence interval 0.47 to 0.82). Based on two trials, the caesarean section rate with oral misoprostol was 20. 2% (55/272) compared with 15.5% (42/270) for vaginal prostaglandins (relative risk 1.29, 95% confidence interval 0.90 to 1.86). Different doses (100 micrograms three hourly and 200 micrograms six hourly) were used in the two trials that compared oral with vaginal misoprostol. The caesarean section rate was 21.8% in the oral misoprostol group compared with 13.5% for vaginal misoprostol (relative risk 1.62, 95% confidence interval 0.85 to 3.09). The uterine hyperstimulation rate with oral misoprostol was 37.5% (36/96) compared with 28% (25/89) for vaginal misoprostol (relative risk 1.32, 95% confidence interval 0.86 to 2.04). There was significant heterogeneity between these two trials. REVIEWER'S CONCLUSIONS: Oral misoprostol may be an effective method for labour induction. However clinically effective oral regimens may have an unacceptably high incidence of uterine hyperstimulation and possibly uterine rupture.

Female↗
PubMed2006

Medical treatment for early fetal death (less than 24 weeks).

BACKGROUND: In most pregnancies that miscarry, arrest of embryonic or fetal development occurs some time (often weeks) before the miscarriage occurs. Ultrasound examination can reveal abnormal findings during this phase by demonstrating anembryonic pregnancies or embryonic or fetal death. Treatment before 14 weeks has traditionally been surgical but medical treatments may be effective, safe, and acceptable, as may be waiting for spontaneous miscarriage. OBJECTIVES: To assess the effectiveness, safety and acceptability of any medical treatment for early pregnancy failure (anembryonic pregnancies or embryonic and fetal deaths before 24 weeks). SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2005). SELECTION CRITERIA: Randomised trials comparing medical treatment with another treatment (e.g. surgical evacuation), or placebo, or no treatment for early pregnancy failure. Quasi-random studies were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted unblinded. MAIN RESULTS: Twenty four studies (1888 women) were included. Vaginal misoprostol hastens miscarriage (complete or incomplete) when compared with placebo: e.g. miscarriage less than 24 hours (two trials, 138 women, relative risk (RR) 4.73, 95% confidence interval (CI) 2.70 to 8.28), with less need for uterine curettage (two trials, 104 women, RR 0.40, 95% CI 0.26 to 0.60) and no significant increase in nausea or diarrhoea. Lower-dose regimens of vaginal misoprostol tend to be less effective in producing miscarriage (three trials, 247 women, RR 0.85, 95% CI 0.72 to 1.00) with similar incidence of nausea. There seems no clear advantage to administering a 'wet' preparation of vaginal misoprostol or of adding methotrexate, or of using laminaria tents after 14 weeks. Vaginal misoprostol is more effective than vaginal prostaglandin E in avoiding surgical evacuation. Oral misoprostol was less effective than vaginal misoprostol in producing complete miscarriage (two trials, 218 women, RR 0.90, 95% CI 0.82 to 0.99). Sublingual misoprostol had equivalent efficacy to vaginal misoprostol in inducing complete miscarriage but was associated with more frequent diarrhoea. The two trials of mifepristone treatment generated conflicting results. There was no statistically significant difference between vaginal misoprostol and gemeprost in the induction of miscarriage for fetal death after 13 weeks. AUTHORS' CONCLUSIONS: Available evidence from randomised trials supports the use of vaginal misoprostol as a medical treatment to terminate non-viable pregnancies before 24 weeks. Further research is required to assess effectiveness and safety, optimal route of administration and dose. Conflicting findings about the value of mifepristone need to be resolved by additional study.

Abortifacient Agents↗
PubMed1991

Pharmacokinetics of benzydamine after intravenous, oral, and topical doses to human subjects.

The pharmacokinetics of the anti-inflammatory drug benzydamine were determined after intravenous infusion of 5 mg to six healthy male subjects. Benzydamine was characterized as a drug of relatively low systemic clearance (ca. 160 ml min-1) but high volume of distribution (ca. 1101); the apparent terminal half-life in plasma was ca. 8 h. Benzydamine was well absorbed after oral administration, as indicated by a mean systemic availability of 87 per cent. However, absorption of the drug was low (less than 10 per cent of the dose) after its use by male subjects as a mouthwash, or after its application to female subjects as dermal cream and vaginal douche preparations. The data suggest that benzydamine is generally not well absorbed through the skin and non-specialized mucosae, thereby limiting unrequired systemic exposure to this drug when it is used by these routes.

Administration, Cutaneous↗
PubMed1991

Pharmacokinetics and bioavailability of papaverine HCl following intravenous, peroral, rectal, vaginal, topical and buccal administration in beagle dogs.

This in vivo study was designed to obtain bioavailability data and a definite pharmacokinetic profile of papaverine HCl in Beagle dogs following intravenous (IV), peroral (PO), rectal, vaginal, topical, and buccal administration of different papaverine HCl formulations. Blood samples were analyzed by high-performance liquid chromatography. The pharmacokinetic parameters were determined using either a curve fitting program (RESID) or a compartment model independent program (AUC-RPP). The plasma concentration-time profiles show that papaverine HCl pharmacokinetics is best described by an open two-compartment model. The absolute bioavailability of papaverine HCl was determined to be 57.2 per cent, 25.2 per cent, 53.2 per cent, 3.2 per cent and 7.5 per cent, respectively, following P.O., rectal, vaginal, topical and buccal administration.

Administration, Buccal↗
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↗
PubMed2002

Systemic and mucosal immune responses in mice after rectal and vaginal immunization with HIV-DNA vaccine.

We examined the feasibility of inducing local and systemic human immunodeficiency virus (HIV)-specific immune responses by rectal and vaginal application of an HIV-DNA vaccine. Mice were immunized with an HIV-DNA vaccine preparation via a rectal or vaginal route. After several applications, HIV-specific antibodies were detected in sera, fecal extract solutions, and vaginal washes, and these antibodies were potent in inhibiting the syncytium formation of a CD4-positive human T cell line by a cell line capable of inducing HIV-1 infection. Spleen cells from rectally and vaginally immunized mice showed antigen-mediated IFN-gamma-inducing activity. In addition, with rectal immunization, mononuclear cells from both the spleen and the regional lymph nodes of the rectal region were found to be potent at inducing a cytotoxic T lymphocyte response. These humoral and cell-mediated immune responses were enhanced by augmenting the vaccine with granulocyte-macrophage colony-stimulating factor-expressing plasmids or IL-12-expressing plasmid. Our results demonstrated that both rectal and vaginal immunization could induce systemic and mucosal immunity and that these responses were enhanced by the addition of the above cytokine-expressing plasmids.

AIDS Vaccines↗
PubMed1997

Estrogen replacement therapy in women with prior diagnosis and treatment for breast cancer.

We followed 49 women who underwent a minimum of 2 years estrogen replacement therapy (ERT) after diagnosis and treatment for localized breast cancer. Forty-three women were treated with oral ERT. In this group, the median age at the time of cancer diagnosis was 46 years (range 26 to 66 years), and ERT was begun a median of 84 months after diagnosis (range 0 to 286 months). The patients were followed for a median of 144 months after cancer diagnosis (range 46 to 324 months), and the median duration of ERT was 31 months (range 24 to 142 months). For six women, ERT was administered as a vaginal cream application. In this group, the median age at time of cancer diagnosis was 46 years (range 38 to 57 years), and ERT was begun a median of 49 months after diagnosis (range 24 to 61 months). The patients were followed for a median of 95 months after cancer diagnosis (range 72 to 154 months), and the median duration of ERT was 47 months (range 27 to 80 months). One patient experienced disease recurrence; she had received surgery for a stage I, estrogen receptor (ER)-positive lesion. The patient began ERT 30 months after cancer diagnosis and developed a recurrent ER-negative tumor 56 months after initiation of ERT. She remained alive without evidence of disease for 10 years since initial diagnosis of breast cancer. Despite the inherent limitations of retrospective experiential data and the need for prospective, randomized trials to assess the safety of ERT, the present observations suggest that ERT does not appear to have a pronounced adverse effect on cancer outcome. Nevertheless, until appropriate clinical trials determine that ERT is safe, caution is needed.

Administration, Intravaginal↗