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PubMedDate not supplied

Comparison of intra-amniotic (15S)-15-methyl-PGF2 alpha and intravaginal prostaglandin E2 for second-trimester uterine evacuation.

OBJECTIVE: To compare the efficacy, safety, and side effects of intra-amniotic (15S)-15-methyl prostaglandin F2 alpha (15-M-PGF2 alpha) and intravaginal prostaglandin E2 (PGE2) for midtrimester uterine evacuation. STUDY DESIGN: Ninety-three patients underwent therapeutic midtrimester pregnancy termination by the use of laminaria placement and intra-amniotic injection of 15-M-PGF2 alpha. A matched control group underwent uterine evacuation by laminaria placement and insertion of PGE2 intravaginal suppositories. The main outcomes studied were time to delivery, side effects, and complications. RESULTS: The 15-M-PGF2 alpha group had a shorter time to delivery (12.3 +/- 6.4 hours) compared with the PGE2 group (16.2 +/- 6.6 hours, p < 0.0001). The evacuation rate over time was significantly greater in the 15-M-PGF2 alpha group (p = 0.001). The PGE2 group had a significantly higher incidence of side effects. CONCLUSIONS: The use of intra-amniotic 15-M-PGF2 alpha for therapeutic second-trimester pregnancy termination is safe and is associated with a more rapid evacuation of the uterus and fewer side effects than intravaginal PGF2 suppositories.

Abortifacient Agents, Nonsteroidal↗
PubMed2004

Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen.

Because of its potential as a low cost first-line monotherapy for the most common vulvovaginal infections, we evaluated fenticonazole nitrate in a prospective, open-label, multicenter pilot study with 101 sexually active women (per-protocol; 16 to 61 years of age) with vulvovaginitis involving single or mixed infections with Candida albicans, Trichomonas vaginalis, and/or Gardnerella vaginalis. Fenticonazole nitrate (1 g) was administered as vaginal ovules, once daily on days 1 and 3. Eradication (direct phase-contrast microscopy of vaginal swabs and/or microbiological culture) on day 8 was 90% (C. albicans, 26/29, p < 0.001), 70% (T. vaginalis, 7/10, p = 0.161), 67% (G. vaginalis, 22/33, p < 0.009), and 45% (mixed infection, 13/29, p = 0.001). After 28 days, relapse was 0% for candidiasis and trichomoniasis, 27% (6/22) for G. vaginalis, and 23% (3/13) for mixed infection. Overall, eradication of all offending pathogens was achieved in 67% of the total per-protocol population, with a relapse rate of only 16%. Score sums for symptoms improved from 7.0 (baseline) to 1.7 (day 8), and 0.71 (day 28), (p < 0.001). Treatment was safe and well tolerated. The results of our pilot study suggest that application of fenticonazole nitrate 1 g intravaginal ovules on 2 alternate days is a suitable first-line treatment of vulvovaginitis with acceptable broad-spectrum efficacy against the most commonly involved pathogens and with a low rate of early relapse, reserving antibiotics for patients with treatment failure or relapse of infection. Our results should encourage further examination of this approach in larger and well controlled clinical trials.

Administration, Intravaginal↗
PubMed2003

Disruption of the upper female reproductive tract epithelium by nonoxynol-9.

Spermicides containing nonoxynol-9 (N-9) may increase HIV transmission. In women, intravaginal N-9 is found in the uterus shortly after its insertion. Exposure of the female upper reproductive tract to N-9 may alter epithelial integrity, thereby increasing HIV transmission risk. Our goal was to characterize the histological effects of N-9 on uterine epithelium in an animal model. Female mice were exposed to intravaginal or intrauterine Advantage-S (N-9), Replens, K-Y(R) jelly or water. After various exposure times, mice were sacrificed and stained uterine tissue sections were analyzed by a pathologist blinded to treatment.Intravaginal and intrauterine N-9 administration resulted in disruption of uterine epithelium compared to Replens, K-Y jelly or water. N-9 caused rapid (within 10 min), focal, uterine epithelial sloughing and complete epithelial loss within 24 h. Epithelial regeneration began 48 h after exposure N-9 and was completely restored within 72 h; the new epithelial layer, however, was composed of cuboidal cells instead of normally present columnar cells. In addition, hemorrhage and necrosis were present are all time points examined. Our results demonstrate for the first time that N-9 has a deleterious effect on uterine epithelium. Although these results were observed in a mouse model, similar disruption of the upper reproductive tract epithelium in women by N-9 may facilitate HIV infection and serve as an unrecognized portal of human HIV transmission.

Administration, Intravaginal↗
PubMed1991

Sequential outpatient application of intravaginal prostaglandin E2 gel in the management of postdates pregnancies.

A randomized blinded investigation was undertaken to determine the efficacy and safety of sequentially applied intravaginal prostaglandin E2 (PGE2) gel for accelerating cervical ripening in an outpatient setting in low-risk prolonged pregnancies. Fifty women with uncomplicated pregnancies at or beyond 41 weeks' gestation and Bishop scores below 9 received twice-weekly outpatient administration of gel containing 2.0 mg of PGE2 or placebo. Thirty nulliparas and 20 multiparas were enrolled. The PGE2 gel failed to improve cervical ripening over placebo, as judged by Bishop scores. There was no difference between the groups in gestational age on admission to the labor and delivery suite, number of gel applications, requirement for oxytocin, incidence of cesarean delivery, or neonatal outcome. Only two patients (4%) experienced regular uterine contractions after gel insertion; these subsided spontaneously in both. None of the subjects experienced labor, tetanic contractions, evidence of fetal distress, or any other side effects related to gel insertion. We conclude that PGE2 gel in this dosage may be used safely in an outpatient setting, but more frequent application or earlier initiation may be required to produce a clinical effect.

Administration, Intravaginal↗
PubMed2004

Intravaginal immunization with viral subunit protein plus CpG oligodeoxynucleotides induces protective immunity against HSV-2.

Although the genital tract has been considered a poor inductive site for immunization with non-replicating antigens, genital immunization may be important for protection against sexually transmitted infections. Recently, we and others showed that CpG oligodeoxynucleotides (ODNs) serve as potent adjuvants for mucosal immunization. The purpose of this study was to determine whether intravaginal (IVAG) immunization with recombinant glycoprotein B (rgB) of herpes simplex virus type 2 (HSV-2) plus CpG ODN can induce specific immunity and protect against genital HSV-2 challenge. C57BL/6 mice were immunized IVAG with rgB plus CpG ODN, rgB plus non-CpG ODN, or rgB alone and challenged IVAG with HSV-2. Mice immunized with rgB + CpG had higher levels of anti-gB IgA and IgG in the vaginal washes and serum compared to mice immunized with rgB alone. Mice immunized with rgB + CpG also had the highest levels of gB-specific IgG in the nasal washes, however no specific IgA was detected in the nasal washes of any group. Mice immunized IVAG with rgB + CpG showed higher survival and lower pathology scores following genital HSV-2 challenge than mice immunized with rgB + non-CpG ODN or rgB alone. Additionally, vaginal viral titers were lower in the rgB + CpG group after infection. These results clearly show that the genital tract is capable of generating a protective immune response after local intravaginal immunization and that a non-replicating antigen is able to induce such a response when administered with an appropriate adjuvant.

Administration, Intranasal↗
PubMed2003

Influence of silicone elastomer solubility and diffusivity on the in vitro release of drugs from intravaginal rings.

The in vitro release characteristics of eight low-molecular-weight drugs (clindamycin, 17beta-estradiol, 17beta-estradiol-3-acetate, 17beta-estradiol diacetate, metronidazole, norethisterone, norethisterone acetate and oxybutynin) from silicone matrix-type intravaginal rings of various drug loadings have been evaluated under sink conditions. Through modelling of the release data using the Higuchi equation, and determination of the silicone solubility of the drugs, the apparent silicone elastomer diffusion coefficients of the drugs have been calculated. Furthermore, in an attempt to develop a quantitative model for predicting release rates of new drug substances from these vaginal ring devices, it has been observed that linear relationships exist between the log of the silicone solubility of the drug (mg x ml(-1)) and the reciprocal of its melting point (K(-1)) (y=3.558x-9.620, R=0.77), and also between the log of the diffusion coefficient (cm(2) s(-1)) and the molecular weight of the drug molecule (g x mol(-1)) (y=-0.0068x-4.0738, R=0.95). Given that the silicone solubility and silicone diffusion coefficient are the major parameters influencing the permeation of drugs through silicone elastomers, it is now possible to predict through use of the appropriate mathematical equations both matrix-type and reservoir-type intravaginal ring release rates simply from a knowledge of drug melting temperature and molecular weight.

Administration, Intravaginal↗
PubMedDate not supplied

Vaginal misoprostol in managing premature rupture of membranes.

We compared the efficacy of misoprostol with that of prostaglandin E2 in cervical ripening and labour induction. Thus 238 women with rupture of membranes beyond 36 weeks gestation without labour were randomized to receive 50 microg misoprostol vaginal gel or 5 mg of prostaglandin E2 gel. Bishop score was evaluated before drug application and 6 hours later. Clinical data and perinatal outcome were recorded. Mean time from induction to delivery and the need for oxytocin were significantly less in the misoprostol group. There were no significant differences in spontaneous labour rate, type of delivery and perinatal outcome. It is concluded that intravaginal misoprostol is safe and more effective than prostaglandin E2 for preinduction cervical ripening in premature rupture of membranes beyond 36 weeks gestation.

Administration, Intravaginal↗
PubMed1996

Randomized, double-blind trial of prostaglandin E2 intravaginal gel versus low-dose oxytocin for cervical ripening before induction of labor.

OBJECTIVE: Our purpose was to compare two methods of preinduction cervical ripening in a randomized, double-blind clinical trial. STUDY DESIGN: Two intravaginal, 4 mg prostaglandin E2 gel applications administered 4 hours apart were compared with 10 hours of low-dose oxytocin (2 mU/min) in 200 patients undergoing preinduction cervical ripening. RESULTS: There were no differences in parity, initial Bishop scores, estimated gestational ages, indications for induction, or birth weights. Prostaglandin E2 gel was significantly better (p < 0.0001) at achieving a change in the Bishop score of 3 or more. The number of successful inductions was significantly greater (p < 0.0003) and the mean time to active labor was significantly shorter (p < 0.0002) in the prostaglandin E2 group than in the oxytocin group. More multiple-day inductions (p < 0.01) occurred in the oxytocin group, and fewer discharged patients who did not deliver infants (p < 0.03) were seen in the prostaglandin E2 gel group. There were no differences between patient groups in the cesarean section rate, meconium staining, hyperstimulation, and Apgar scores. CONCLUSION: Two 4 mg doses of prostaglandin E2 intravaginal gel applied 4 hours apart are superior to low-dose oxytocin in producing cervical ripening and preparing for successful induction.

Administration, Intravaginal↗
PubMed1993

Effect of low intravaginal doses of prostaglandin E2 on the closure time of the ductus arteriosus in term newborn infants.

Seventeen term newborn infants (control subjects) and 17 whose mothers had been given intravaginal doses of prostaglandin E2 (PGE2) were examined serially by color Doppler echocardiography to determine whether maternal PGE2 prolonged ductal patency. No clinically relevant differences in closure times were found. Low-dose intravaginal PGE2 therapy was not associated with prolonged ductal patency in term infants.

Administration, Intravaginal↗
PubMed1991

[Pharmacological studies of intravaginally applied dehydroepiandrosterone sulfate (DHA-S)].

The ripening effect of dehydroepiandrosterone sulfate (DHA-S) on the uterine cervix was studied after intravaginal application. A 100-mg suppository containing 0, 5, 10 or 20% (w/w) DHA-S was applied to the vagina of pregnant rats 3 times on days 14-16 of gestation. Wet weight and water content of the uterine cervix increased dose-dependently. To measure the elasticity of the uterine cervix, the tension causing an expansion of 1 mm or 2 mm was determined; this was reduced by the application of 20% DHA-S, and the difference in the length of the cervix produced by tensions of 5 g and 25 g was increased. Application of 20% DHA-S decreased the collagen content of the uterine cervix and the total collagenase activity was increased. Furthermore, histochemical changes, coarsening and edema were observed in the uterine cervix. These findings suggest that intravaginal application of DHA-S would produce ripening effects similar to those after intravenous injection.

Administration, Intravaginal↗
PubMed2000

Induction of labor by prostaglandin E(2) in relation to the Bishop score.

OBJECTIVE: To compare the effectiveness of prostaglandin E(2) intravaginal gel with the intracervical gel in patients with an unfavorable cervix. METHOD: In a prospective multicenter trial 470 patients with unfavorable Bishop scores (3-4) were randomized to receive prostaglandin vaginal gel (2 mg) or intracervical gel (0.5 mg). RESULTS: In patients with unfavorable Bishop scores the intravaginal application route resulted in a better cervical ripening, a shorter induction to delivery interval and a higher cumulative rate of deliveries during 24 h (P=0.01). CONCLUSION: Intravaginal instillation of prostaglandin E(2) gel for induction of labor is effective in patients with an unfavorable Bishop score of 3-4.

Administration, Intravaginal↗
PubMed2006

Bishop score and the outcome of labor induction with misoprostol.

BACKGROUND: The aim of the study was to retrospectively identify possible factors for predicting the outcome of induction with misoprostol. METHODS: Fifty micrograms of misoprostol were administered intravaginally every 6 h during the first 2 days of induction, up to a maximum of 4 doses. The Bishop score, indication for induction, gestational length, maternal age, and parity were analyzed. The study involved 99 patients (47 primiparous and 52 multiparous) at term (>36 weeks of gestation) with unripe cervices. RESULTS: Forty-five per cent of the patients achieved ripening of cervix and went into labor after a single dose of misoprostol; a further 45% required 2 doses. Nine patients received more than 2 tablets. Ninety-seven per cent of all vaginal deliveries occurred within the first 2 days of induction. Ninety-five per cent of the patients delivered vaginally when the Bishop score was >3, compared with 75% of those with a Bishop score of < or =3 (p=0.003). Among factors creating the Bishop scoring system, in logistic regression analysis effacement of the cervix was the only independent, significant predictor of cesarean section (p=0.003, OR = 0.16) even after adjusting for maternal age, which also was a significant predictor in the regression analysis. Eleven patients had previously had a cesarean section; one of them had a uterine rupture with a fatal outcome for the fetus. All women with a previously scarred uterus are now excluded from misoprostol treatment. CONCLUSION: Misoprostol 50 microg administered intravaginally every 6 h according to this protocol is highly effective for inducing labor in carefully selected patients with unripe cervices.

Administration, Intravaginal↗
PubMed1987

The in vitro effect of chemical intravaginal contraceptives on Chlamydia trachomatis.

The effect of four intravaginal chemical contraceptives on the in vitro growth of Chlamydia trachomatis in cycloheximide-treated McCoy cells was studied. Encare produced significant inhibition, while Koromex had little antichlamydial activity. Both Intercept and Conceptrol had an intermediate effect, reducing chlamydial replication to 60-70% compared to untreated controls. Some variation in these effect against different strains of Chlamydia has been observed. In addition, the antichlamydial properties observed do not seem to be solely mediated by the pH of the preparations or the concentration of nonoxynol-9, the active ingredient in these contraceptives. Thus, intravaginal contraceptives may have a role in decreasing asymptomatic transmission of this organism and possibly as an adjunct to antibiotic therapy in symptomatic patients.

Administration, Intravaginal↗
PubMed1998

Fertility regulation in cattle.

This paper reviews the physiological, endocrinological and pharmaceutical literature pertaining to the design, development and optimisation of subcutaneous and intravaginal progestogen-containing drug delivery systems used in the control of synchrony and ovulation in cattle.

Administration, Cutaneous↗
PubMed2003

Mesenteric vein thrombosis associated with intravaginal contraceptives: a case report and review of the literature.

Mesenteric vein thrombosis (MVT) is a distinct clinical cause of intestinal ischemia representing 5-15% of all ischemic events. MVT has acute, subacute, and chronic presentations and an underlying cause can be found in nearly 75% of cases. Exogenous hormones are used worldwide by millions of women for contraception and postmenopausal replacement therapy. Current preparations include oral, transdermal, and intravaginal delivery systems. The risk of venous and arterial thrombosis with oral preparations is well established, however the risk with parenteral preparations has not been fully established. The mechanisms underlying these increased risks have not been fully elucidated. We report a case of mesenteric vein thrombosis associated with intravaginal hormonal contraception. A review of the current literature reveals no prior reports of this complication of intravaginal or transdermal hormonal therapy. When taking a medical history, it is imperative for physicians to be aware of all medications, including those not taken orally.

Administration, Intravaginal↗
PubMed1999

[Therapeutic regimens for treating bacterial vaginosis in pregnant women].

The study comprises 128 pregnant women examined at different gestational weeks. The diagnosis of bacterial vaginosis was made using: a) the complex clinical criteria--vaginal discharge, vaginal pH, amine test and "clue cells" b) Nugent scoring system c) Spiegel criteria. Two therapeutic regimens were compared--intravaginal 2% clindamycin creme (Dalacin V) 5 g three consecutive days and intravaginal metronidazole (Flagyl) 500 mg once daily for 5 consecutive days. Control examination was carried out 5-7 days after completion of therapy using the same protocol. 28 women from the first group and 31 women from the second group had the control examination. Bacterial vaginosis was eradicated in 93% of women using intravaginal clindamycin and in 87% of women using intravaginal metronidazole. Both regimes were more effective compared to treatment with oral ampicillin for 7 days, where the cure rate was 62%.

Administration, Intravaginal↗
PubMed2003

Absorbable deslorelin implants (Ovuplant) prolong postpartum anestrus in early ovulating dairy cows.

Two experiments were conducted to investigate the use of a bioabsorbable implant of the GnRH agonist deslorelin to temporarily delay the resumption of postpartum ovulatory cycles in Holstein cows. In Experiment 1, recently calved cows were paired and received either a single implant (Ovuplant); Peptech Animal Health, Sydney, NSW, Australia) within 48 h of parturition (OVP; n=17), or remained as untreated controls (CON; n=17). Blood samples were collected for plasma progesterone assay three times weekly for 6 weeks to profile the pattern of resumption of ovulatory cycles. In Experiment 2, there were 15 CON and 15 OVP cows initially treated as for Experiment 1 as well as 15 OVP+SYNCH cows. Each cow in the CON and OVP+SYNCH groups received a progesterone vaginal insert (CIDR); Genetics Australia, Bacchus Marsh, Vic., Australia) for 7 days at 23 days postpartum (23 dpp) to synchronise estrus in cycling animals or to induce an ovulation with estrus in anestrus animals. Blood samples were collected weekly until removal of the CIDR insert, and then twice weekly until 56 dpp to monitor plasma P4 for retrospective determination of ovulation. Milk yield was monitored by twice daily electronic volume measurements and milk composition with once weekly milk composition analysis. In Experiment 1, CON cows began ovulating from 9 dpp; 15 of 17 had ovulated by the end of blood sampling at 42 dpp. None of the OVP cows ovulated until at least 24 dpp, and only 6 of 17 had ovulated by 42 dpp. The average day of first ovulation was extended from 22.4+/-2.7 dpp to 39.3+/-2.7 dpp (P<0.05). In Experiment 2, ovulation had occurred in 8 of 15 CON cows at the time of CIDR insertion (23 dpp), 0 of 15 OVP cows and 1 of 15 OVP+SYNCH cows. By 40 dpp (or 10 days following removal of the CIDR insert) every CON cow (15/15) had ovulated, but only 2 of 15 OVP+SYNCH cows and 1 of 15 OVP cows. None of these effects of treatment was associated with any changes in milk yield or composition in either experiment. In conclusion, inserting a bioabsorbable implant of deslorelin within 48 postpartum extended the interval to first ovulation to at least 24 dpp in 46 of 47 cows. Recovery periods were highly variable. This variability was not reduced by using a form of intravaginal progesterone supplementation that did produce a synchronised estrus with ovulation in anestrus animals that had not been treated with deslorelin.

Absorption↗
PubMed2000

A randomized trial of intravaginal nonoxynol 9 versus oral metronidazole in the treatment of vaginal trichomoniasis.

OBJECTIVE: This study was undertaken to investigate the efficacy of nonoxynol 9 suppositories in the treatment of vaginal trichomoniasis. STUDY DESIGN: In this prospective comparison trial 46 women with documented motile trichomonads found on a wet preparation were randomly assigned to one of two treatment arms: (1) a single oral dose of 2 g metronidazole and (2) a single 150-mg nonoxynol 9 suppository placed intravaginally for 3 consecutive nights. Cure was determined by a repeated wet preparation examination. After its first year, the study was terminated because of the poor efficacy of the nonoxynol 9 suppositories. RESULTS: Results were available for 33 patients. Three of 17 patients treated with nonoxynol 9 had negative wet preparation results at retest (17.6% cure rate). All 16 patients treated with metronidazole had negative wet preparation results (100% cure rate). All women with nonoxynol 9 failures who were evaluated after treatment with 2 g metronidazole had negative wet preparation results. CONCLUSION: Intravaginal nonoxynol 9 at the tested dose and by the tested method of delivery was not an effective cure for vaginal trichomoniasis.

Administration, Intravaginal↗