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PubMed2000

High-performance liquid chromatographic determination of 17beta-estradiol and 17beta-estradiol-3-acetate solubilities and diffusion coefficents in silicone elastromeric intravaginal rings.

A rapid, sensitive reversed-phase high-performance liquid chromatographic method has been developed for the determination of in vitro release of 17beta-estradiol and its ester prodrug, 17beta-estradiol-3-acetate, from silicone intravaginal rings. Partial hydrolysis of the acetate under the aqueous conditions provided by the 1% benzalkonium chloride release medium necessitates its conversion to 17beta-estradiol prior to HPLC analysis. Both steroid peaks have been fully resolved from the benzalkonium chloride peaks by the reported chromatographic method, which employs a C18 bonded reversed-phase column, an acetonitrile-water (50:50, v/v) mobile phase and a UV detection wavelength of 281 nm. The peak area versus 17beta-estradiol concentration was found to be linear over the range of 0.0137-1347 microkg ml(-1). The HPLC method has also been used to determine the silicone solubilities and diffusion coefficients of the two related steroids. The almost 100-fold increase in 17beta-estradiol-3-acetate release from the silicone core-type intravaginal rings compared to 17beta-estradiol is shown to be due to a 60-fold increase in silicone solubility and a one and a half-fold increase in diffusitivity. The results demonstrate that an effective estrogen replacement therapy dose of 17beta-estradiol may be administered from a silicone intravaginal reservoir device containing the labile 17beta-estradiol-3-acetate prodrug.

Administration, Intravaginal↗
PubMed2006

Women's satisfaction with an intravaginal Lactobacillus capsule for the treatment of bacterial vaginosis.

OBJECTIVE: To assess women's satisfaction with a vaginal capsule containing human-derived, H(2)O(2)-producing Lactobacillus crispatus at completion of a randomized, placebo-controlled study for treatment of bacterial vaginosis (BV). METHODS: Women aged 14-35 years with BV were randomized to Lactobacillus or placebo intravaginal capsule twice daily for 3 days monthly for 3 months. Attitudes were assessed with a standardized scale at the final follow-up visit, and associations of satisfaction with clinical and gram stain cure of BV were determined. RESULTS: Four hundred twenty-four women were randomized at enrollment, and 232 (55%) provided data on satisfaction at the final visit. Overall, satisfaction with the capsule was high and was independent of subjects' race, age, and prior history of BV. Report of satisfaction with the capsule, belief that it contained healthy bacteria, and belief that its use improved vaginal health were directly related to clinical cure and to improved Nugent score. Except for women who had BV at the final follow-up visit, most subjects believed that the capsule contained healthy bacteria independent of any outcome reflecting cure. Willingness to use the capsule again was not significantly related to whether subjects experienced clinical cure or normalization of Nugent score at either visit. Adverse effects were rare and were largely related to a perceived difference in vaginal discharge. CONCLUSIONS: Satisfaction with an intravaginal capsule and positive beliefs about its use for BV treatment were prevalent, especially among women with a clinical and microbiological response to BV therapy. However, most women expressed willingness to use the product again regardless of clinical response. Acceptability of and interest in alternative BV treatments, such as L. crispatus intravaginal applications, are high.

Administration, Intravaginal↗
PubMed2001

In-vitro and in-vivo evaluation of a matrix-controlled bromocriptine mesilate-releasing vaginal ring.

The aim of this study was to evaluate the in-vitro release rates and in-vivo effectiveness of a controlled release, intravaginal dosage form of bromocriptine mesilate. The dimeticone (poly(dimethylsiloxane)) elastomer vaginal ring contained 3 mg bromocriptine mesilate and low molecular weight gelatin in a ratio of 1:3, and 10% propylene glycol. The daily release rate of the drug was designed to be 10% of the total administered dose and was confirmed with release experiments under sink conditions. The effect of the vaginal ring preparation on plasma prolactin level in the rabbit was investigated over a 10-day period. The results showed that the vaginal ring of bromocriptine mesilate significantly decreased the plasma prolactin level of the test group (P < 0.001-0.05) compared with the control and placebo groups. It was concluded that bromocriptine mesilate was effectively absorbed from rabbit vagina and that this controlled release intravaginal ring preparation of bromocriptine mesilate was effective in decreasing the plasma prolactin level in rabbits for ten days.

Administration, Intravaginal↗
PubMed1997

[Safety and efficacy of intravaginal misoprostol for cervical ripening in the third trimester of pregnancy].

OBJECTIVE: To evaluate the safety and efficacy of intravaginal misoprostol for cervical ripening in late trimester. METHOD: A randomized, double-blind, placebo-controlled trial was conducted. 85 patients with indication for induction of labor and unfavorable cervices were randomly assigned to receive either intravaginal misoprostol (100 micrograms) or placebo placed in the posterior vaginal fornix at one time. The Bishop score, fetal heart rate monitoring and Doppler blood flow velocity waveforms were measured before and 12 hours after drug insertion. Placenta and decidua were observed histopathologically in some cases. Among 85 patients enrolled, 43 received misoprostol and 42 received placebo. RESULTS: The mean initial Bishop scores were not significantly different between the two groups, while the mean Bishop score in the misoprostol group was significantly higher than that in the placebo group (4.4 for misoprostol versus 1.0 for placebo, P < 0.01). The prevalence of spontaneous labor within 12 hours after misoprostol insertion (67.4%, 29/43) was significantly higher than that in the placebo group (14.3%, 6/42) (P < 0.01). The average Doppler velocity systolic to diastolic (S/D) ratios of umbilical artery, middle cerebral artery, renal artery were not significantly different before and 12 hours after drug insertion between both groups. There was no significant difference in frequency of abnormal fetal heart rate tracings or fetal distress and in the mean Apgar score between the two groups. Except the presence of vasodilation in villi vessels in the misoprostol group, no significant difference existed between the two groups in the placental and decidual histopathological changes. CONCLUSION: Intravaginal misoprostol may be an effective and safe cervical ripening agent in late pregnancy.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

High-dose misoprostol used in outpatient management of first trimester spontaneous abortion.

AIM: The aim of this study was to evaluate the efficacy and tolerance of a high dose of vaginal misoprostol for outpatient medical management of missed abortion. METHODS: Three doses of 400 mug misoprostol were administered intravaginally every 4 h daily, for a maximum period of 3 days, to 108 women with uneventful first trimester pregnancy failure. RESULTS: A total of 98 women (90.7%) were managed successfully, with 74 (68.5%) of them within the first 24 h. The mean dose of misoprostol administered was 1,113.0 microg (range 400-3,600 microg), and the mean time required was 19.5 h (range 7-65 h). Only 6 out of 108 women (9.3%) required surgical intervention as the result of retained products of conception. The side effect profile was minimal. CONCLUSION: This protocol of 400 mug intravaginally misoprostol every 4 h as three daily doses for a maximum of 3 days, may offer an efficacious and safe alternative to the outpatient management of first-trimester missed abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy.

OBJECTIVE: To study the effect of raloxifene on the response to conjugated estrogen cream or nonhormonal moisturizer in postmenopausal women with preexisting signs of vaginal atrophy. METHODS: Postmenopausal women with preexisting and untreated vaginal atrophy were enrolled in this parallel, placebo-controlled, randomized study. A total of 187 women were randomized to four treatment groups: daily oral raloxifene (60 mg per day) or a placebo in a double-blind manner plus one application of conjugated estrogen cream (0.5 g) or one applicator full of nonhormonal moisturizer, open label. The conjugated estrogen cream or nonhormonal moisturizer was applied daily for the first 2 weeks, and then twice weekly thereafter for 3 months. Efficacy of treatment regimens on signs and symptoms of vaginal atrophy was evaluated by monitoring objective and subjective parameters. RESULTS: Signs and symptoms of vaginal atrophy improved in all four treatment groups. Raloxifene did not diminish the magnitude of improvement when administered with either vaginal preparation. Conjugated estrogen cream produced a statistically greater improvement in signs (P <.05) but not in individual symptoms or overall satisfaction relative to nonhormonal moisturizer. CONCLUSION: Postmenopausal women with evidence of preexisting vaginal atrophy may use either low-dose conjugated estrogen cream or nonhormonal moisturizer to treat the atrophy concurrently with raloxifene (60 mg per day).

Administration, Intravaginal↗
PubMed2003

Effect of dietary intake on steroid feedback on release of luteinizing hormone in ovariectomized cows.

This study tested the hypothesis that the decline in pulsatile release of luteinizing hormone (LH), resulting from steroid negative feedback, is greater in animals fed a low, compared with a high, plane of nutrition. Two-year-old cows were ovariectomized and six days later were fed diets to provide 1.5 x maintenance requirements (n = 6, supplemented) or 0.5 x maintenance requirements (n = 6, restricted) (Round 1). Pulsatile release of LH was measured over a 14-h period on the fifth day of feeding these diets (Day 1); at 6 h, all animals were treated with an intravaginal insert containing 1.38 g progesterone, which remained in place until the end of Day 3. Pulsatile release of LH was again measured for 14 h on Day 3; at 6 h, all animals were injected intramuscularly with oestradiol benzoate (ODB; 1 mg per 500 kg live weight). Three days later, this protocol was repeated, in a cross-over design, with cows that were previously restricted now being supplemented and those cows previously supplemented, now restricted (Round 2). Plasma concentrations of progesterone after intravaginal progesterone treatment were 1.01 ng mL(-1) higher in restricted cows compared with supplemented cows (P < 0.001) and were also higher in Round 1 than in Round 2 and on Day 1 than on Day 3 (P < 0.001). Plasma concentrations of oestradiol following injection with ODB did not differ between supplemented and restricted cows (P > 0.1). Dietary intake did not affect mean concentrations of LH, pulse frequency or amplitude during the 6-h period before steroid treatment or the change in these variables following steroid treatment; however, the slope of the decline in concentrations of LH following progesterone treatment was significantly more negative in cows fed restricted diets compared with those fed supplemented diets. In Round 2, mean concentrations of LH were higher preceding, and decreased more following, progesterone treatment compared with the decrease after ODB treatment. In conclusion, acute dietary restriction resulted in a more rapid decline in the release of LH following treatment with intravaginal progesterone, and was associated with higher concentrations of progesterone in plasma.

Administration, Intravaginal↗
PubMed2003

Simian-human immunodeficiency virus SHIV89.6-induced protection against intravaginal challenge with pathogenic SIVmac239 is independent of the route of immunization and is associated with a combination of cytotoxic T-lymphocyte and alpha interferon responses.

Attenuated primate lentivirus vaccines provide the most consistent protection against challenge with pathogenic simian immunodeficiency virus (SIV). Thus, they provide an excellent model to examine the influence of the route of immunization on challenge outcome and to study vaccine-induced protective anti-SIV immune responses. In the present study, rhesus macaques were immunized with live nonpathogenic simian-human immunodeficiency virus (SHIV) 89.6 either intravenously or mucosally (intranasally or intravaginally) and then challenged intravaginally with pathogenic SIVmac239. The route of immunization did not affect mucosal challenge outcome after a prolonged period of systemic infection with the nonpathogenic vaccine virus. Further, protection from the SIV challenge was associated with the induction of multiple host immune effector mechanisms. A comparison of immune responses in vaccinated-protected and vaccinated-unprotected animals revealed that vaccinated-protected animals had higher frequencies of SIV Gag-specific cytotoxic T lymphocytes and gamma interferon (IFN-gamma)-secreting cells during the acute phase postchallenge. Vaccinated-protected animals also had a more pronounced increase in peripheral blood mononuclear cell IFN-alpha mRNA levels than did the vaccinated-unprotected animals in the first few weeks after challenge. Thus, innate as well as cellular anti-SIV immune responses appeared to contribute to the SHIV89.6-induced protection against intravaginal challenge with pathogenic SIVmac239.

Administration, Intravaginal↗
PubMed1994

[PgE2 gel and PgE2 vaginal tablets for induced labor--a prospective randomized study].

In a prospective randomised study, the effects of an intracervical gel containing 0.5 mg PgE2 and an intravaginal tablet containing 3 mg PgE2 were compared in their efficiency to induce delivery at term. When only gel was used, induction failed in 45% of the cases, especially with an initially immature cervix score. However, these patients did show significant improvement of the Bishop score. The vaginal tablet was more effective with regard to the induction of delivery. When using the vaginal tablet alone, induction failed in only 5% of cases (p < 0.001). Best results, however, were obtained with a combination of both application forms. In this group there were no failures. Tablet application induced delivery within 24 hours in 56% of the cases, gel application in only 27% (p < 0.001). There were no significant differences observed in these groups during the course of labour. The length of the latency period was identical, whether a tablet or a gel was used in initiating labour. In 29% of the cases, beta-sympathicomimetics had to be used because of tetanic contractions or polysystolia. No significant differences in the occurrence of these contractions were seen in either the gel or the tablet group. Even in a high-risk collective with 25% pathological Doppler-flow findings, no higher rate of operative deliveries or fetal acidoses was observed after prostaglandin induction, if careful surveillance of the patients and early use of tocolytics in experienced hands were administered. Our results further confirm the concept of a differential induction of labour with prostaglandins.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed1991

Patterns of uterine activity after intravaginal prostaglandin E2 during preinduction cervical ripening.

In a randomized study, uterine activity patterns were characterized with a portable pressure-sensitive device in 40 nonlaboring women at term with an unfavorable cervix who were undergoing preinduction cervical ripening with prostaglandin E2. The prostaglandin E2 was inserted into the posterior vaginal fornix as a single dose of either a 2.5 mg methylcellulose gel (20 cases) or 10 mg controlled-release pessary (20 cases). Uterine activity monitoring began 1 hour before dosing and continued for 12 hours. For those treated with the gel, low-amplitude, high-frequency contractions began within the first hour, reached a peak within 4 hours, and initiated sustained high-amplitude contractions in 10 (50%) cases. With the controlled-release pessary, low-amplitude, high-frequency contractions had a slightly later onset, reached a peak between the fifth and eighth hours, and initiated sustained high-amplitude contractions in 18 (80%) cases. Uterine hyperstimulation occurred in two (10%) pessary cases, with no adverse effect after removal. We conclude that low-amplitude, high-frequency uterine contractions began with either method of intravaginal prostaglandin E2 delivery but led to sustained, high-amplitude contractions primarily with the pessary.

Administration, Intravaginal↗
PubMed2006

Role of misoprostol in overcoming an unsatisfactory colposcopy: a randomized double-blind placebo-controlled clinical trial.

OBJECTIVE: To assess the effectiveness of vaginal misoprostol in overcoming an unsatisfactory colposcopy and to analyse the factors that might influence the response to misoprostol, i.e. age, menopausal status, duration of menopause and cervical characteristics. STUDY DESIGN: A randomized double-blind placebo-controlled clinical trial. METHODS: Forty patients with unsatisfactory colposcopy were recruited from the colposcopy clinic and were randomly allocated to receive either 400 microg misoprostol or similar-looking placebo tablets vaginally. Repeat colposcopy was performed after 6 h noting the side effects, if any. RESULTS: One patient was excluded from the misoprostol group because postdrug colposcopic examination could not be done due to a technical fault. Of the 19 patients in the misoprostol group, 15 (78.9%) had satisfactory examination compared to only 6 of the 20 (30%) patients in the placebo group. This effect of misoprostol was statistically significant (p = 0.004). Misoprostol in the present study averted 3 cone biopsies and 12 endocervical curettages. The side effects of misoprostol were comparable in both groups. The slit-like external os and the posterior cervical lip as the site of unsatisfactory colposcopy had better conversion rates compared to pinhole os (66.6 vs.81.2%) and anterior lip involvement (85.7 vs.100%). CONCLUSION: Four hundred micrograms of intravaginal misoprostol is an effective and safe method to convert an unsatisfactory colposcopy into a satisfactory one.

Administration, Intravaginal↗
PubMed1997

Induction of labor with intravaginal misoprostol versus intracervical dinoprostone.

Sixty five pregnant women who had the indication for labor induction were randomized in a clinical trial to receive 100 micrograms intravaginal misoprostol or intracervical gel of 0.5 mg dinoprostone. The mean time from induction to delivery for the misoprostol group was 7.6 +/- 1.9 versus 8.2 +/- 5.9 (hours +/- SD) for the dinoprostone group. There were no significant differences between groups in gestational age, induced labor rates, type of delivery, fetal outcome and maternal complications. We found that intravaginal misoprostol tablet is as effective as intracervical dinoprostone for inducing second and third trimester labor.

Administration, Intravaginal↗
PubMed1995

Methotrexate and misoprostol to terminate early pregnancy.

BACKGROUND: Although medical termination of pregnancy is available in Europe and China as an alternative to surgical termination, political and social factors have blocked medical approaches to pregnancy termination in the United States. Methotrexate, which is toxic to trophoblastic tissue, has been used safely to treat unruptured ectopic pregnancies. This report describes the use of a single low dose of methotrexate followed by intravaginal misoprostol for the medical termination of early pregnancy. METHODS: Women seeking termination of pregnancy were selected for this study on the basis of their good general health, emotional stability, and a pregnancy of 63 days or less in duration. Each woman received an intramuscular dose of methotrexate (50 mg per square meter of body-surface area). Five to seven days later, 800 micrograms of misoprostol was administered intravaginally. If abortion did not occur after seven days, the women was offered a second dose of misoprostol or vacuum aspiration. Successful abortion was defined as a complete termination of pregnancy within seven days after the first or second administration of misoprostol. RESULTS: A total of 171 of the 178 women enrolled in the study (96 percent) had successful medical abortions. Twenty-five women (14 percent) did not have an abortion after the first dose of misoprostol and received a second dose. Eighteen subsequently had complete abortions, but seven required suction curettage. In all seven women who required suction curettage, there was histologic evidence of disruption in the conceptus. No important side effects or complications were noted. CONCLUSIONS: The combination of methotrexate and misoprostol represents a safe and effective alternative to invasive methods for the termination of early pregnancy.

Abortion, Legal↗
PubMed1992

Controlled vaginal delivery of antibodies in the mouse.

Controlled delivery of monoclonal antibodies to the mucus secretions of the vagina might provide women with passive immunoprotection against both sexually transmitted diseases and unwanted pregnancy. We have developed intravaginal devices composed of poly(ethylene-co-vinyl acetate) (EVAc) that continuously release IgG antibodies for over 30 days into buffered saline, and we have tested these devices in the vagina of mice. Polymeric devices containing either BSA (as a test reagent for proteins) or anti-hCG antibody, when inserted into the vaginas of mice, provided a continuous supply of either BSA or hCG-binding antibodies to the vaginal mucus for 30 days. Antibodies released by the devices achieved high concentration in the mucus within the lumen of the vagina, but did not significantly ascend into the uterine horns, as determined by epifluorescence microscopy of fluorescently labeled mouse IgG and by immunohistochemical localization of rabbit IgG. Our results suggest that long-term intravaginal delivery of functionally intact antibodies can be achieved with devices composed of EVAc.

Administration, Intravaginal↗
PubMed1993

Intravaginal misoprostol as a cervical ripening agent.

OBJECTIVE: To determine if misoprostol (exogenous prostaglandin E1 PGE1) used vaginally was of value in improving the Bishop score, leading to an early safe vaginal delivery in women in whom the cervix is unripe and delivery is indicated. DESIGN: A double-blind clinical trial. SETTING: Antenatal and labour wards of the University Hospital of the West Indies, Jamaica. SUBJECTS: Forty-five women in the third trimester with various obstetric indications for induction of labour and with no contra-indications to prostaglandins. INTERVENTIONS: The women were randomly assigned to receive treatment or a placebo. The treated group had 100 micrograms misoprostol inserted vaginally while the placebo was similarly inserted. MAIN OUTCOME MEASURES: Efficacy of the misoprostol was measured by the increase in the Bishop score 12 h after giving the treatment, the time between insertion and delivery, the need for oxytocin, and the outcome of the pregnancy. RESULTS: The prostaglandin was superior to the placebo in ripening the cervix and inducing labour. The change in Bishop score was 5.3 in the misoprostol group compared with 1.5 in the placebo group (P < 0.001). The mean time from insertion to delivery was 15.6 h in the former while it was 43.2 h in the placebo group (P < or = 0.001). The need for oxytocin was also significantly less in the women receiving the prostaglandin compared with those who received the placebo (29% vs 62%, P < 0.02). There was no difference in the two groups in the delivery outcome in terms of complications, Apgar scores and mode of delivery. CONCLUSIONS: Intravaginal misoprostol is an effective and cheap method of inducing labour in the third trimester.

Administration, Intravaginal↗
PubMed1992

Prelabour rupture of the membranes at term and unfavourable cervix; a randomized placebo-controlled trial on early intervention with intravaginal prostaglandin E2 gel.

Fifty nine women with prelabour rupture of membranes, unfavourable cervix and no evidence of infection or fetal distress were randomized formally to receive prostaglandin E2 (3mg) gel or sterile K-Y Jelly intravaginally. Conservative expectant management was followed for the next 24 hours. The subsequent management of the labour followed departmental protocol. The women who received prostaglandin went into labour sooner and were delivered earlier but the duration of labour was not significantly different. There were no significant differences in other clinical outcomes. There was 1 case of uterine rupture in the prostaglandin group. We conclude that early intervention with prostaglandin E2 gel intravaginally confers no advantage compared with conservative management except for earlier confinement in this group of patients.

Administration, Intravaginal↗
PubMed2003

Low dose intravaginal misoprostol versus intracervical baloon catheter for pre-induction cervical ripening.

BACKGROUND: The efficacy and safety of low dose misoprostol as a ripening agent compared to the widely used balloon catheter in developing countries is undetermined. OBJECTIVE: To compare the safety and efficacy of a low dose intravaginal misoprostol and intracervical Foley's catheter for cervical ripening. DESIGN: A prospective randomized controlled trial. SETTING: Zonal General Hospital, Kwale, Nigeria from June 1, 1998 to May 30, 2001. METHODS: Candidates for pre-induction cervical ripening were randomized to receive either 250 mcg of intravaginal misoprostol every four hours (n = 60) or intracervical Foley's catheter (n = 61). MAIN OUTCOME MEASURES: Failure to achieve cervical ripening within 24 hours, need for augmentation, maternal and foetal complications. RESULTS: Failure to achieve cervical ripening within two hours was reduced with misoprostol (Relative Risk [RR] 0.63, 95% Confidence Interval [CI] 0.43 - 0.92). Need for oxytocin augmentation was less in the misoprostol group (RR 0.76, 95% CI 0.64 to 0.91). No significant differences existed in rates for uterine hyperstimulation, Caesarean section, maternal and neonatal morbidity. CONCLUSION: Intravaginal misoprostol in a low dose was compared to intracervical balloon catheter for pre-induction ripening of the cervix.

Administration, Intravaginal↗