[Induced labor using intravaginal administration of tablets containing prostaglandin E2].
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[Intravaginal administration of progesterone (PRID), in the treatment of cystic ovarian follicles in cattle, in which gonadotropin-releasing hormone therapy failed (author's transl)].
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Animals↗
[Intravaginal PgE2 administration for inducing labor in premature rupture of fetal membranes].
In a prospective study, 121 patients with spontaneous rupture of the membranes of greater than 6 hours duration and unfavourable Bishop-Score (less than 6) were stimulated with 3 mg vaginal prostaglandin-E2-tablets. All patients started labour. Only one patient had a hyperstimulation which was corrected with betamimetics. There were no systemic side effects. Almost 90% of the women delivered on the first day. The rate of the Caesarean sections was low. There was no case of intraamniotic infection; the foetal outcome was good. In conclusion, vaginal prostaglandin-E2-tablets are safe to use in spontaneous rupture of the membranes.
Administration, Intravaginal↗
Early pregnancy termination with intravaginally administered sodium chloride solution-moistened misoprostol tablets: historical comparison with mifepristone and oral misoprostol.
OBJECTIVE: The purpose of this study was to compare the abortifacient effect of intravaginally administered moistened misoprostol tablets with that of the combination regimen of mifepristone and oral misoprostol. STUDY DESIGN: One hundred women at </=56 days' gestation received 800 microg misoprostol intravaginally in the form of sodium chloride solution-moistened tablets. The dose was repeated 24 hours later if a gestational sac persisted on ultrasonographic examination. These 100 subjects (group 1) were then matched with 100 subjects who had received 600 mg mifepristone followed by 400 microg misoprostol orally as part of a large multicenter American trial (group 2). Subjects were monitored for abortion success, adverse side effects, and bleeding characteristics. Abortion failure was defined as persistence of an intrauterine sac or the need to perform a surgical evacuation of the uterus for hemorrhage, for incomplete abortion, or at the subject's request. RESULTS: In 88 of the 100 women in group 1 and 94 of the 100 women in group 2, abortion occurred and a surgical procedure was not required. Abortion rates were not influenced by gestational age in either group. Prostaglandin-related side effects of fever and chills, vomiting, diarrhea, and uterine pain were all significantly higher in group 1. Excessive uterine bleeding was uncommon in both groups, and no subjects received blood transfusions. CONCLUSION: The abortion rate with intravaginally administered moistened misoprostol tablets is similar to that with the combination of mifepristone and oral misoprostol. However, intravaginal administration of misoprostol is associated with significantly more prostaglandin-related side effects.
Abortifacient Agents, Nonsteroidal↗
[Basic principles of hormone replacement therapy in the postmenopause].
17 beta-estradiol, conjugated equine estrogens, esterified estrogens, and estriol constitute postmenopausal replacement therapy, all of which are in clinical use as oral preparations. Non-oral routes--matrix and reservoir patches, gel--were developed for estradiol, as was the intravaginal administration of estriol and estradiol. Daily doses of 1 mg estradiol(valerate) or 25 micrograms estradiol delivered via a patch or 0.5 mg gel or 0.3 mg conjugated equine estrogens are often sufficient to alleviate climacteric symptoms. Bone resorption may be effectively reduced and bone mineral density maintained by 1 mg estradiol or 25 micrograms transdermal estradiol. Maximal bone sparing dosages are 2 mg estradiol, 50 micrograms transdermal estradiol, 0.625 mg conjugated equine estrogens, and 1.25 mg estrone Estriol, predominantly used for the prevention and or treatment of urogenital symptoms, has no bone sparing effect at the doses in clinical use. Non-oral administration of estradiol may be superior in diabetic women and those with hypertriglyceridemia due to the different metabolism which does not mainly involve the hepatic first pass effect. Epidemiological data do not support any preference of oral versus non-oral routes of administration regarding side-effects such as venous thromboembolism. Progestogens--natural progesterone, derivatives structurally related to progesterone and testosterone, respectively--are necessary for endometrial protection. Sequential use of a progestogen for at least 10 days per month, preferably 12-14 days abolishes the increased incidence of endometrial hyperplasia which is likely to develop with unopposed use of estrogen. Observational studies do not suggest any superiority of a given progestogen regarding cardiovascular risk, prevention of osteoporosis, and cognitive function in postmenopausal women on estrogen replacement therapy. Tibolone, a derivative of norethindrone, is yet another option for replacement therapy. The recommended dose for treatment of climacteric symptoms and prevention of bone loss is 2.5 mg. Controlled clinical studies do not suggest that this compound is superior in achieving amenorrhea compared with continuous combined estrogen progestogen replacement therapy, as available data are inconsistent. In early postmenopause the sequential use of a progestogen in conjunction with an estrogen is the preferred treatment option. With advancing postmenopausal age either continuous combined replacement or tibolone may be choices in case withdrawal bleeding is no longer acceptable for women. However, there are no rigid age limit when to change treatments, the selection of which is largely influenced by the preference of the individual's acceptance of withdrawal bleeding.
Administration, Cutaneous↗
Medicated tampons: intravaginal sustained administration of metronidazole and in vitro-in vivo relationships.
The technical feasibility of utilizing tampons as a drug delivery system for prolonged intravaginal drug administrations was studied. Several commercially available brands of tampons were examined. The methodology for the incorporation of various doses of metronidazole, an antitrichomonas agent, in tampons was described. The sustained-release profile of metronidazole from these medicated tampons was characterized. Intravaginal administration of metronidazole via the medicated tampons was investigated in rhesus monkeys and human volunteers, and in vitro-in vivo correlations were established. The biopharmaceutics of intravaginal absorption of metronidazole via medicated tampons was analyzed in comparison with a vaginal solution formulation.
Absorption↗
Buccal versus intravaginal misoprostol administration for cervical ripening.
OBJECTIVE: The purpose of this study was to compare the efficacy of misoprostol that is administered in the buccal pouch with the intravaginal route of administration. STUDY DESIGN: One hundred fifty-seven pregnant women with a singleton live gestation, Bishop score of <7, estimated fetal weight of <4500 g, and gestational age of >24 weeks were randomized to receive misoprostol that would be placed either in the buccal pouch or vagina every 6 hours. In the buccal group, after the first 2 doses of 200 microg, the dose was increased to 300 microg for the duration of the study (up to a total of 1600 microg). In the vaginal group, after the first 2 doses of 50 microg, the dose was increased to 100 microg for the duration of the study (up to a total of 500 microg). The primary outcome variable was the interval from the first dose to vaginal delivery. Power calculations indicated the need to enroll 71 patients in each arm of the study, which would allow for the detection of a 4-hour reduction in vaginal birth interval for buccal misoprostol. RESULTS: The hours from drug administration to vaginal delivery were similar between the buccal and vaginal groups (23.5 +/- 20.8 hours versus 21.3 +/- 13.4 hours), respectively. Thirty-five women (63%) versus 34 women (67%) delivered vaginally within 24 hours (P = not significant). The incidence of tachysystole was higher in the buccal group, 28 occurrences (38%) versus 15 occurrences (19%; P =.01). CONCLUSION: Buccal misoprostol is effective for cervical ripening but results in a higher incidence of tachysystole than does intravaginal administration.
Administration, Buccal↗
Oestrous synchronisation in Ethiopian highland zebu cattle by means of intravaginal cloprostenole administration.
Two series were used in studying the use of a low dose of intravaginal cloprostenole in oestrous synchronisation of zebu cows. In series I, 39 cows were given 175 mcg of cloprostenole with a plastic catheter in the anterior vagina twice, with a 12-day interval. After treatment, 61.5% of these cows came into heat, were inseminated and 70 days later pregnancies were confirmed in 66.6% of inseminated cows. In series II, intravaginal treatment (40 cows) was compared with intramuscular administration (33 cows) of 500 mcg of cloprostenole. After treatment the cows were checked for silent heat in addition to visible heat. The overall oestrous response, for both visible and silent heat, was 62.6% and 60.6% after the intravaginal and the intramuscular treatments respectively, and there was no statistical difference between the 2 treatments. Unfortunately the pregnancy of the cows could not be checked. Intravaginal administration of 175 mcg of cloprostenole resulted in good oestrous synchronisation and pregnancy rate. For zebu cattle, the oestrous synchronisation response was similar to that reached with 500 mcg of cloprostenole administered intramuscularly.
Administration, Intravaginal↗
[Cytotec: an effective drug for the induction of labor].
OBJECTIVE: Our purpose was to compare the safety and efficacy of intravaginal Cytotec versus Oxytocin for induction of labor. STUDY DESIGN: Two hundredth seventy six of patients with indications for induction of labor were assigned to receive either intravaginal Cytotec or Oxytocin. Cytotec were placed in the posterior vaginal fornix every three (3) hours with a potential maximum of six (6) doses. Oxytocin were administered to a standard protocol of our clinic. RESULTS: Among those evaluated 138 received Cytotec and 137 received Oxytocin. The overage interval from start of induction to vaginal delivery was shorter in the Cytotec group (1332.4 +/- 846.5 min) than in the Oxytocin group (1523 +/- 705.6 min). There were no significant differences in the routes of delivery. 20.7% of the Cytotec treated patients and 28% of the Oxytocin treated patients required abdominal delivery. CONCLUSIONS: Intravaginal administration of Cytotec appears to be as effective as Oxytocin labor induction.
Administration, Intravaginal↗
Second-trimester uterine evacuation: A comparison of intra-amniotic (15S)-15-methyl-prostaglandin F2alpha and intravaginal misoprostol.
OBJECTIVE: Our purpose was to compare the efficacy, safety, and adverse effects of intra-amniotically administered (15S)-15-methyl-prostaglandin F(2alpha) and intravaginally administered misoprostol for second-trimester uterine evacuation. STUDY DESIGN: Fifty-one patients were randomly assigned to receive either a single 2.5-mg intra-amniotic injection of (15S)-15-methyl-prostaglandin F(2)(alpha) (n = 26) or two 200-microg intravaginal doses of misoprostol (n = 25) at 12-hour intervals. The primary outcome measured was evacuation of the uterus within 24 hours. RESULTS: The mean time from initiation of termination to uterine evacuation was less in the prostaglandin group than in the misoprostol group (17.5 +/- 8.6 hours vs 22.3 +/- 12.5 hours), but this was not statistically significant (P >.05). The rate of successful fetal evacuation at 24 hours was significantly higher in the prostaglandin group than in the misoprostol group (88% vs 60%, P =.02). The complete-abortion rate and the incidence of adverse effects were similar in both groups. CONCLUSION: The use of an intra-amniotic injection of (15S)-15-methyl-prostaglandin F(2alpha) for midtrimester pregnancy termination is safe and is associated with a greater number of successful uterine evacuations within 24 hours, without an increase in adverse effects, than intravaginal administration of misoprostol.
Abortifacient Agents, Nonsteroidal↗
Effect of vaginally administered fumagillin on the morphology of implantation stage endometrium in the rhesus monkey.
Intravaginal administration of an anti-angiogenic agent, fumagillin, during blastocyst implantation, inhibits pregnancy establishment in a dose-related manner in the rhesus monkey. In the present study, mated female rhesus monkeys were vaginally inserted with tampons containing vehicle (group 1; n = 5) and test agent (fumagillin, 4 mg/animal; group 2; n = 6) on cycle day 20, and endometrial tissue samples were collected on cycle day 24 from all monkeys and processed for morphometric and ultrastructural analysis. Concentrations of estradiol-17beta, progesterone and chorionic gonadotrophin in peripheral circulation were determined. From serum profiles of hormones, two monkeys in group 1, and one animal in group 2 appeared pregnant. Endometrial morphology revealed histologic evidence of pregnancy in three of six fumagillin-treated animals, while other three fumagillin-treated animals showed degenerative changes in glands and venules along with marked extravasation. It is possible that the function of corpus luteum was affected by fumagillin treatment resulting in inadequate progesterone production (p <0.05), and consequent inadequate endometrial secretory preparation and receptivity, as revealed from decline in apical movement of vacuoles (p <0.05) and increase (p <0.05) in extravasation of red cells and leukocytes.
Administration, Intravaginal↗
Effect of vaginally administered (Ala(8,13,18))-magainin II amide on the morphology of implantation stage endometrium in the rhesus monkey (Macaca mulatta).
Intravaginal administration of an anti-microbial agent, (Ala(8,13,18))-magainin II amide, during blastocyst implantation inhibits pregnancy establishment in a dose-related manner in the rhesus monkey (Macaca mulatta). In the present study, mated female rhesus monkeys were vaginally inserted with tampons containing vehicle (Group 1; n = 5) and test agent (magainin, 0.5 mg/animal; Group 2; n = 6) on cycle day 20. Endometrial tissue samples were collected on Cycle Day 24 from all monkeys and processed for morphometric and ultrastructural analysis. Concentrations of estradiol-17beta, progesterone, and chorionic gonadotrophin in peripheral circulation were determined, which revealed that two monkeys in Group 1 were pregnant while no animals were pregnant in Group 2. Endometrial morphology, however, revealed histologic evidence of pregnancy in three out of the six magainin-treated animals. It appears that intra-vaginal administration of magainin II amide had a marginal effect on the implantation stage endometrium and the initiation of the implantation process in the rhesus monkey.
Administration, Intravaginal↗
Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol.
OBJECTIVES: To compare the effectiveness of 25 microg vs. 50 microg of intravaginal misoprostol for cervical ripening and labor induction beyond 41 weeks' gestation. METHODS: The study population consisted of 120 women not in active labor with a gestational age >41 weeks, singleton pregnancy with vertex presentation, reactive fetal heart rate tracing, amniotic fluid index >/=5, and Bishop score <5. Women were randomized to receive either 25 microg (n=60) or 50 microg (n=60) of intravaginal misoprostol. The dose was repeated every 4 h (maximum number of doses limited to six) until the patient exhibited three contractions in 10 min. The main outcome measure was the induction-vaginal delivery interval. RESULTS: There was no significant difference between the two groups with regard to the induction-vaginal delivery interval (685+/-201 min in the 25 microg group vs. 627+/-177 min in the 50 microg group, P=0.09). The proportion of women delivering vaginally with one dose of vaginal misoprostol was significantly greater in the 50 microg group (0/49 vs. 41/47, P<0.001). There were no differences in the rates of cesarean and operative vaginal delivery rates, or in the incidences of tachysystole and hyperstimulation syndrome in the two treatment groups. Neonatal outcomes were also similar. CONCLUSIONS: Intravaginal administration of 25 microg of misoprostol appears to be as effective as 50 microg for cervical ripening and labor induction beyond 41 weeks' gestation.
Administration, Intravaginal↗
A comparative trial of labor induction with misoprostol versus oxytocin.
OBJECTIVE: To determine the efficacy and safety of intravaginal misoprostol compared with intravenous oxytocin in cervical ripening and labor induction. METHOD: The study was carried out at the Department of Obstetrics and Gynecology at the Hospital Loayza, Lima, Peru. The sample included 123 pregnant women with any indication for labor induction. The study was prospective and randomized. We compared the effect of 50 micrograms of intravaginal misoprostol administered every 4 h up to 600 micrograms with that observed using the standard protocol of oxytocin by continuous infusion. RESULTS: 57 patients with misoprostol (group 1) and 63 with oxytocin (group 2) were enrolled. Delivery occurred in 45 patients (78.9%) in group 1 and in 37 (58.7%) in group 2 (P < 0.017). Complications including tachysystole, uterine hypertony and hyperstimulation were higher in group 1, 21.1% than in group 2, 7.9% (P < 0.04). The incidence of cesarean section in both groups was similar to the overall incidence in our center. No differences were observed between groups in perinatal and postpartum adverse outcomes. The interval from start of induction to vaginal delivery was significantly shorter in the oxytocin group (8.4 +/- 4.1 vs. 11.3 +/- 6.9 h, P < 0.005). CONCLUSION: Intravaginal administration of misoprostol is a safe and effective alternative for cervical ripening and labor induction. Maternal and neonatal complications did not increase significantly.
Abortifacient Agents, Nonsteroidal↗
Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.
OBJECTIVE: To evaluate the safety and clinical effectiveness of intravaginal misoprostol, a synthetic prostaglandin E1 analogue, for labor induction in gravidas with premature rupture of membranes (PROM) at term. METHODS: One hundred forty-one pregnant women with term PROM were assigned randomly to one of two induction groups: 1) intravaginal misoprostol or 2) intravenous oxytocin by continuous infusion. RESULTS: Seventy subjects were allocated to the misoprostol group and 71 to the oxytocin group. The mean (+/- standard deviation) interval from induction to delivery was significantly shorter in the misoprostol group (416 +/- 276 compared with 539 +/- 372 minutes; P = .04). In 85.7% of patients in the misoprostol group, only one dose was required. Intrapartum complication rates, mode of delivery, and neonatal or maternal adverse event rates were similar in the two treatment groups. Uterine tachysystole occurred more frequently with misoprostol than with oxytocin (28.6% compared with 14.0%; P < .04). CONCLUSION: Intravaginal administration of misoprostol induces labor safely and effectively in patients with PROM at term.
Administration, Intravaginal↗
Two-year toxicity and carcinogenicity studies in B(6)C(3)F(1) mice with 5-bromo-6-methoxy-5,6-dihydro-3'-azidothymidine-5'-(p-bromophenyl) methoxyalaninyl phosphate (WHI-07), a novel anti-HIV and contraceptive agent.
The zidovudine derivative, 5-bromo-6-methoxy-5,6-dihydro-3'-azidothymidine-5'-(p-bromophenyl) methoxy alaninyl phosphate (WHI-07), is a dual-function spermicidal and anti-HIV agent with contraceptive and microbicidal activity. In previous two subchronic toxicity studies, intravaginal application of 0.5-2.0% WHI-07, for up to 13 weeks, was shown to cause no local, systemic or reproductive toxicity. To evaluate the toxicity and carcinogenic potential of long-term exposure to WHl-07, groups of 50 female B(6)C(3)F(1) mice were given no treatment or exposed intravaginally to a gel-microemulsion formulation with and without 2.0% WHI-07, 5 days per week for 2 years. The dose of WHI-07 was equivalent to 5700 times its spermicidal EC(50) and 5.7x10(6) times its anti-HIV IC(50). The endpoints that were evaluated included survival, body weight, hematologic and clinical chemistry profiles, absolute and relative organ weights, and histopathology. No significant differences in mean body weight gain and survival were found among the groups of untreated control, placebo control, and 2% WHI-07-treated mice at the end of the 2-year study. The hematological and clinical chemistry profiles did not reveal any toxicologically significant changes that could be attributed to WHI-07 treatment. No clinically significant changes in absolute and relative organ weights were noted in the WHI-07 group. A variety of neoplastic and nonneoplastic lesions which were considered incidental, related to aging, or procedural, were observed in both the untreated and intravaginally treated groups. The proportion of animals with malignant tumors, the total number of malignant tumors, as well as the types of malignant tumors in the three groups was similar. The cumulative incidence of microscopic lesions in various organs showed that malignant lymphoma was the major cause of death in aging female B(6)C(3)F(1) mice, the incidence of which was unaffected by intravaginal treatment. We conclude that long-term intravaginal administration of WHI-07 is not associated with systemic toxicity or increased carcinogenicity in mice. WHI-07 has clinical potential as an active ingredient of a safe vaginal/rectal microbicide.
Administration, Intravaginal↗
A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections.
BACKGROUND: Recurrent urinary tract infections are a problem for many postmenopausal women. Estrogen replacement restores atrophic mucosa, lowers vaginal pH, and may prevent urinary tract infections. METHODS: We enrolled 93 postmenopausal women with a history of recurrent urinary tract infections in a randomized, double-blind, placebo-controlled trial of a topically applied intravaginal estriol cream. Midstream urine cultures were obtained at enrollment, monthly for eight months, and whenever urinary symptoms occurred. Vaginal cultures and pH measurements were obtained at entry and after one and eight months. The women were assigned to receive either estriol (n = 50) or placebo (n = 43), both administered intravaginally; 36 and 24, respectively, completed the eight months of follow-up. RESULTS: The incidence of urinary tract infection in the group given estriol was significantly reduced as compared with that in the group given placebo (0.5 vs. 5.9 episodes per patient-year, P < 0.001). Survival analysis showed that more of the women in the estriol group than in the placebo group remained free of urinary tract infection (P < 0.001). Lactobacilli were absent in all vaginal cultures before treatment and reappeared after one month in 22 of 36 estriol-treated women (61 percent) but in none of the 24 placebo recipients (P < 0.001). With estriol the mean vaginal pH declined from 5.5 to 3.8 (P < 0.001), whereas there was no significant change with placebo. The rate of vaginal colonization with Enterobacteriaceae fell from 67 percent to 31 percent in estriol recipients but was virtually unchanged (from 67 to 63 percent) in the placebo recipients (P < 0.005). Side effects were minor, but caused 10 estriol recipients (28 percent) and 4 placebo recipients (17 percent) to discontinue treatment. CONCLUSIONS: The intravaginal administration of estriol prevents recurrent urinary tract infection in postmenopausal women, probably by modifying the vaginal flora.
Administration, Intravaginal↗
A 13-week subchronic intravaginal toxicity study of pokeweed antiviral protein in mice.
Pokeweed antiviral protein (PAP), a 29-kDa plant-derived protein isolated from Phytolacca americana, is a broad-spectrum antiviral agent. PAP shows unique clinical potential to become the active ingredient of a non-spermicidal microbicide because of its potent in vivo anti-HIV activity, non-interference with in vivo sperm functions, and lack of cytotoxicity to genital tract epithelial cells. Over 13 weeks the subchronic and reproductive toxicity potential of an intravaginally administered gel formulation of PAP was studied in mice to support its further development as a vaginal microbicide. Female B6C3F1 and CD-1 mice in subgroups of 20, were exposed intravaginally to a gel formulation containing 0, 0.025, 0.05, or 0.1% PAP, 5 days/week for 13 consecutive weeks. On a molar basis, these concentrations are 500- to 2000-times higher than the in vitro anti-HIV IC50 value. After 13 weeks of intravaginal treatment, B6C3F1 mice were evaluated for survival, body weight gain, and absolute and relative organ weights. Blood was analyzed for hematology and clinical chemistry profiles. Microscopic examination was performed on hematoxylin and eosin-stained tissue sections from each study animal. Placebo-control and PAP-dosed female CD-1 mice were mated with untreated males in order to evaluate if PAP has any deleterious effects on reproductive performance. There were no treatment-related mortalities. Mean body weight gain was not reduced by PAP treatment during the dosing period. The hemogram and blood chemistry profiles revealed lack of systemic toxicity following daily intravaginal instillation of PAP for 13 weeks. No clinically significant changes in absolute and relative organ weights were noted in the PAP dose groups. Extensive histopathological examination of tissues showed no increase in treatment-related microscopic lesions in any of the three PAP dose groups. Repeated intravaginal exposure of CD-1 mice to increasing concentrations of PAP for 13 weeks showed no adverse effect on their subsequent reproductive capability (100% fertile), neonatal survival (>90%) or pup development. Collectively, these findings demonstrate that repetitive intravaginal administration of PAP at concentrations as high as 2000 times its in vitro anti-HIV IC50 value was not associated with local or systemic toxicity and did not adversely affect the reproductive performance of mice. PAP may be useful as an active ingredient of a safe vaginal microbicide for prevention of the sexual transmission of viruses, particularly of HIV-1.
Administration, Intravaginal↗