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We describe five patients with vaginal stenosis that was due to chronic graft-versus-host reaction after bone marrow transplantation. All patients underwent surgical procedures followed by local corticosteroids administration. Vaginal function was restored in all cases. This satisfactory result persists in the long term.
OBJECTIVE: The purpose of this study was to compare the efficacy and side effects of two different misoprostol regimens for second-trimester pregnancy termination. STUDY DESIGN: We performed a randomized clinical trial in patients who were at 14 to 23 weeks of gestation and who were admitted for medical termination of pregnancy. All patients received 800 microg of vaginal misoprostol and were assigned randomly to 400 microg of oral misoprostol or 400 microg of vaginal misoprostol every 8 hours. Efficacy and side effects were compared. The mean induction time of the study group was compared with that of an historic control group that had received 400 microg vaginally every 12 hours. RESULTS: Forty-three women were assigned randomly, 22 women to vaginal misoprostol and 21 women to oral misoprostol. Induction time and hospital stay were slightly shorter for the oral group; however, the differences were not significant. Side effects were similar for both groups. CONCLUSION: After an initial 800 microg dose of vaginal misoprostol, a regimen of 400 microg of oral misoprostol every 8 hours is as effective as the same dose of vaginal misoprostol with no additional side effects, which provides a convenient alternative for midtrimester pregnancy termination.
We conducted a retrospective study to determine the efficacy and safety of self-administration of vaginal misoprostol (following oral mifeprestone) for medical termination of pregnancy. This study revealed that self-administration was accepted by the majority of the patients (90%) and the success rate (98.4%) and duration of hospital stay was not altered significantly compared to our previous year's data, where women were administered vaginal misoprostol by the staff. Based on this study's results, we are of the opinion that this regimen not only demedicalises the problem but also decreases the workload for the medical staff.
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Insulin is a polypeptide drug and it is degraded by gastrointestinal enzymes, therefore, it cannot be used via oral route readily. There are only parenteral forms available in the market. The aim of this study was to investigate the effect of rectal and vaginal administration of various insulin gel formulations on the blood glucose level as alternative routes in rabbits. Chitosan gel (CH-gel) was used as a carrier; the penetration enhancing effect of sodium taurocholate and dimethyl-beta-cyclodextrin (DM-betaCD) was also investigated. CH-gel provided longer insulin release. The maximum decreasing effect on blood glucose level was observed with insulin-CH-gel containing 5% DM-betaCD. In conclusion, our results indicate that insulin may penetrate well through the rectal and vaginal mucosae from the CH-gel. DM-betaCD was also found to be a useful agent to enhance the penetration of insulin through rectal and vaginal membranes.
In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation. A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 microg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 microg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission. The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose ofmisoprostol, the route of administration ofmisoprostol did not influence the time to abortion. Of the women who received a second dose ofmisoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min). Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.
OBJECTIVES: To determine the efficacy of an application regimen of low-dose frequent misoprostol for second-trimester pregnancy termination. METHODS: A total of 250 women between 12 and 20 weeks of gestation who were scheduled for second-trimester pregnancy termination received 200 microg vaginal misoprostol followed by 100 microg oral misoprostol every 2 h until expulsion of the fetus. Mechanical cervical dilatation with a 16-French Foley balloon catheter was performed if no cervical dilatation was observed after 24 h. The main outcome measures were the delivery rate within 24 h and the factors influencing the interval between the onset of induction and abortion. Secondary outcome measures were the side-effects of the regimen and the total misoprostol dose required. RESULTS: With application of this protocol, 245 women (98%) delivered within 24 h of induction. The mean (+/-standard deviation) misoprostol dose used was 728+/-297 microg (200-2100 microg). Cox regression analysis revealed that vaginal spotting or nulliparity do not effect the induction-abortion time. On the other hand, using this regimen induction to abortion time tends to be longer in the presence of live fetuses (odds ratio (OR) = 0.45; confidence interval (CI) =0.2-0.8; p=0.008) and pregnancies with gestational age > 16 weeks (OR= 0.59; CI = 0.4-0.8; p= 0.003) when compared with cases of in utero death and pregnancies with a gestational age of 12-13 weeks, respectively. Twenty-seven women (10.8%) experienced one or more side-effects attributable to misoprostol. CONCLUSION: The 100-microg oral misoprostol every 2 h following 200 microg vaginal misoprostol is a highly effective protocol for inducing abortion at 12-20 weeks of pregnancy. Cases with live fetuses or pregnancies with older gestational age (> 16 weeks) deliver in a longer time period.
OBJECTIVE: To identify independent predictors of successful labor induction with oral or vaginal misoprostol. METHODS: Women enrolled in four previous randomized trials involving oral or vaginal misoprostol for cervical ripening and labor induction were included in the present cohort study, with dosing of 25-50 microg every 4 to 6 h vaginally (n = 574) or 50 microg every 4 h orally (n = 207). Multiple logistic regression was performed to identify factors independently associated with successful labor induction -- defined as vaginal delivery within 12 h, vaginal delivery within 24 h and spontaneous vaginal delivery. Predictors of Cesarean birth and the need for only one dose of misoprostol were also identified. Variables included in the models were maternal age, weight, height, parity, gravidity, membrane status, route of misoprostol, gestational age, birth weight, and Bishop score and its individual components. RESULTS: Maternal age, height, weight, parity, birth weight, dilatation, effacement and cervical station were associated with vaginal delivery within 24 h of induction. Maternal age, height, weight, nulliparity, birth weight and route of misoprostol were associated with Cesarean birth, with oral misoprostol being associated with a lower rate of Cesarean birth. The need for only one dose of misoprostol was predicted by maternal height, weight, parity, gestational age, Bishop score and route of misoprostol. CONCLUSION: Characteristics of the woman (height, weight, parity), the fetus (birth weight) and some of the individual components of the Bishop score, were associated with successful labor induction, with oral misoprostol being associated with a lower rate of Cesarean birth.
Women were immunized orally, rectally, or vaginally with a recombinant cholera toxin B-containing vaccine to determine which of these mucosal immunization routes generate the greatest levels of antibody in the female genital tract and rectum. ELISA was used to measure concentrations of cholera toxin B-specific IgA and IgG antibody in serum and secretions before and after three immunizations. Each immunization route similarly increased specific IgG in serum and specific IgA in saliva. Only the vaginal route increased IgA antibodies in genital tract secretions and could be shown to induce a local IgG response. However, vaginal immunization failed to produce antibody in the rectum. In a similar fashion, rectal immunization elicited highest concentrations of locally derived IgA and IgG antibody in the rectum but was ineffective for generating antibody in the genital tract. The data suggest that local immunization may induce the greatest immune responses in the female genital tract and rectum of humans.
BACKGROUND: Microbicides are topical compounds that could prevent sexually transmitted infections. Several compounds have demonstrated activity both in vitro and in animal models, but none has been approved for use in humans. METHODS: A review of >100 recent publications from MEDLINE (through October 2005) and abstracts presented at recent conferences was undertaken to describe the current status of microbicide research and to delineate why microbicides are not yet available. RESULTS: More than 15 candidate microbicides are currently being studied in clinical trials. Their mechanisms of action include disruption of the viral membrane by surfactants, maintenance of an acidic vaginal pH, binding to the viral envelope to block receptor binding, and blocking of receptors; they may also be combined with antiretroviral drugs. The development of safe and effective microbicides has been delayed by limitations in understanding the biological processes of human immunodeficiency virus (HIV) transmission, difficulties in extrapolation from animal models, lack of established correlates of protection, and the need to enroll and follow large cohorts of high-risk participants for several years in order to demonstrate efficacy. CONCLUSIONS: Safe and effective topical microbicides are biologically plausible. Several trials that are under way may demonstrate the ability of microbicides to protect against transmission of HIV, but multiple challenges remain.
In recent years, AIDS and sexually transmitted diseases (STDs) have become a burgeoning problem and are spreading at an alarming rate. Microbicides are being developed as a new therapeutic category for prevention of transmission of sexually transmitted infections (STIs) and HIV. Many of the microbicide formulations (MF) may fail to elicit a protective response either because of a lack of efficacy or inadequate formulation. Manufacturing a stable, efficacious, safe, and optimal product is the main objective of formulation development programs. Preformulation parameters (PP), as discussed in Part I of this series, influence formulation development significantly and should be considered carefully before designing a formulation strategy. Initially, based on PP and market research, a target product profile (TPP) is generated, which defines product attributes that can be normally classified as "essential" and "desirable." A complex and dynamic process begins thereafter that takes into consideration myriad factors starting from selection of delivery system, selection of excipients, compatibility study, prototype composition, selection of process and optimization, stability testing, scale up, manufacturing under good manufacturing practices (GMP), and packaging development. Prototype formulations are evaluated for several performance characteristics (e.g., dispersion behavior, bioadhesion, retention, spreading, rheology). These compositions are also subjected to biologic evaluation by various in vitro and in vivo models. Such a well-planned, well-coordinated, and well-implemented formulation development program not only accelerates overall development but also minimizes failures in subsequent clinical development studies. The objective of this review is to highlight the importance of formulation science, outline the steps involved in this process, and explore how these can be exploited for achieving optimal MF.
This study aimed to compare the efficacy of micronized progesterone administered as luteal support following ovulation induction for in-vitro fertilization (IVF)- embryo transfer in cycles using gonadotrophin-releasing hormone agonist, either orally (200 mgx4/day) or vaginally (100 mgx2/day) and to characterize the luteal phase hormonal profile during such treatments. A total of 64 high responder patients requiring intracytoplasmic sperm injection due to male factor infertility were prospectively randomized into two treatment groups. Patients treated orally or vaginally were comparable in age (31.9 +/- 6.1 versus 30.6 +/- 5.2; mean +/- SD), number of oocytes retrieved (17 +/- 8.2 versus 18 +/- 7.0), and number of embryos transferred (3.1 +/- 1.2 versus 2.7 +/- 0.9) per cycle. Following low dose vaginal treatment, a significantly higher implantation rate (30.7 versus 10.7%, P < 0.01), but similar clinical pregnancy rate (47.0 versus 33.3%) and ongoing pregnancy rate (41.1 versus 20.0%) was observed, compared with oral treatment. In conception cycles, luteal serum progesterone and oestrogen concentrations did not differ between the treatment groups. In non-conception cycles, late luteal progesterone concentrations were significantly lower following vaginal treatment. As low dose micronized progesterone administered vaginally is simple, easy and well tolerated, it could be recommended as the method of choice for luteal support, especially for high responder patients at risk for ovarian hyperstimulation syndrome.
It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable.
BACKGROUND: A prospective randomized controlled trial was conducted to compare the efficacy and side-effects of vaginal versus oral misoprostol in the medical management of incomplete miscarriage. METHODS: Two hundred and one patients who miscarried consented to randomization using computer-generated randomization model prior to treatment. A total of 800 microg of misoprostol was given either vaginally or orally to the randomized subjects. A second dose was repeated 4 h later if the product of conception had not been passed. RESULTS: The incidence of complete uterine evacuation following vaginal and oral misoprostol was similar [(58/95) 61.1% versus (67/103) 64.4%]. There was a significantly decreased incidence of diarrhoea [(12/95) 13.6% versus (62/103) 65.3%, P < 0.01] with the use of vaginal misoprostol. CONCLUSIONS: Vaginal misoprostol was as effective as oral misoprostol in medical uterine evacuation in patients with incomplete miscarriage. There was also a reduction in the incidence of diarrhoea with the use of vaginal misoprostol.
BACKGROUND: The pharmacokinetic parameters of four different routes of administration of a single dose of 400 microg of misoprostol were studied. METHODS: A total of 40 women undergoing termination of pregnancy by suction evacuation was randomized by computer model to receive 400 microg of misoprostol by one of four routes: (i) sublingual (ii) oral (iii) vaginal and (iv) vaginal with addition of water. Venous blood samples were taken at 0, 1, 2, 5, 10, 20, 30, 45, 60, 120, 240 and 360 min after the administration of misoprostol. Misoprostol acid (MPA) was determined in serum samples using gas chromatography/tandem mass spectrometry. RESULTS: Sublingual misoprostol achieved the highest serum peak concentration (Cmax) (574.8 +/- 250.7 pg/ml) of MPA and this was significantly higher than those in the other groups [Oral: 287.6 +/- 144.3 pg/ml (P < 0.01), vaginal: 125.2 +/- 53.8 pg/ml (P < 0.001) and vaginal with water: 162.8 +/- 57.1 pg/ml (P < 0.001)]. The time to peak concentration (Tmax) was similar in both the sublingual (26.0 +/- 11.5 min) and oral groups (27.5 +/- 14.8 min) and was significantly shorter than those in both vaginal groups. The area under the MPA concentration versus time curve up to 360 min in the sublingual group (743.7 +/- 291.2 pg.h/ml) was significantly greater than those in oral (402.8 +/- 151.6 pg.h/ml, P < 0.05) and vaginal (433.7 +/- 182.6 pg.h/ml, P < 0.05) groups, but no significant difference was found between sublingual and vaginal administration if water (649.3 +/- 333.8 pg.h/ml) was added. CONCLUSION: The new sublingual route of administration of misoprostol demonstrated a great potential to be developed into a method of medical abortion.
BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05). CONCLUSIONS: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available.
BACKGROUND: Misoprostol is widely used in combination with mifepristone for medical termination of pregnancy. We studied the endocrine parameters of trophoblast function during medical termination of early pregnancy using mifepristone in combination with oral or vaginal misoprostol. The effect of prolonged misoprostol administration was also examined. METHODS: Thirty-four women, requesting termination of pregnancy and with <or=63 days of amenorrhoea, received 200 mg of mifepristone on day 0, followed by either oral (n = 13) or vaginal (n = 21) administration of 0.8 mg of misoprostol on day 2. In 23 cases misoprostol administration was continued orally for an additional 7 days. Serum samples, collected up to 14 days following the beginning of the treatment, were analysed for hCG, progesterone and mifepristone. RESULTS: hCG and progesterone concentrations continued to increase until day 2. Following misoprostol, hCG and progesterone levels declined by 70.5 +/- 8.8% and 61.3 +/- 16.3% (mean +/- SD) respectively, in 24 h. The percentage decline in hCG correlated inversely (P < 0.05) with the time taken to abort. The peak level of mifepristone measured on day 2 did not correlate with the decline in serum hCG or progesterone. The kinetics of hCG, progesterone and mifepristone were similar in the different treatment groups. CONCLUSIONS: The route and duration of misoprostol administration have no effect on the kinetics of serum hCG or progesterone during medical termination of early pregnancy.
BACKGROUND: A randomized controlled trial comparing sublingual with vaginal administration of misoprostol for medical management of silent miscarriages. METHODS: Eighty women who had silent miscarriages (<13 weeks) were randomized to receive 600 micro g of misoprostol every 3 h for a maximum of three doses either sublingually or vaginally. RESULTS: The success rates of medical management were the same in both groups (87.5%; 95% CI: 74-95%). There were no serious complications. The incidence of diarrhoea was higher in the sublingual (70%) than the vaginal route (27.5%) (P < 0.005). Other side effects were similar in each group, although fatigue was experienced by more women in the sublingual group than in the vaginal group (65 versus 40%: P = 0.043). The overall acceptability of medical management was good. Most women would choose the medical method if they were allowed to choose again and would recommend the method to others. CONCLUSION: The current regimen of misoprostol is useful for the management of silent miscarriage in terms of complete miscarriage rate and patient acceptability. Sublingual misoprostol may offer an alternative for women who do not like repeated vaginal administration of the drug.