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PubMed2000

Estrus synchronization of lactating dairy cows with GnRH, progesterone, and prostaglandin F2 alpha.

The reproductive performance of synchronized cows was compared with that of nonsynchronized cows. In trial 1, cyclic cows in five seasonal herds were randomly divided into two groups. Cows in one group (n = 515) were treated with a GnRH agonist and an intravaginal progesterone device, followed in 7 d by a PGF2 alpha injection, and the device was removed 1 d after PGF2 alpha. Cows in the other group (n = 512) did not receive any treatment and acted as control. In trial 2, the treatments were similar to those used in trial 1 except that the progesterone device was removed at the time of PGF2 alpha injection (synchronized: n = 516; control: n = 512). The estrus synchronization rate was 92.8% in trial 1 and 92.2% in trial 2. Conception rate to first artificial insemination (AI) was lower for synchronized cows than for control cows in trial 1 (56.5 vs. 62.7%), but similar in trial 2 (64.6 vs. 63.3%). Across both trials, the pregnancy rate during the AI breeding period was greater for the synchronized cows (85.6%) than for the control cows (81.2%). The synchronization treatment reduced the interval from start of the breeding season to conception for cows conceiving by AI (8.9 vs. 14.8 d) or by AI or natural mating (14.1 vs. 21.6 d). The synchronization protocol used in trial 2 achieved better conception rate than that used in trial 1, but the precision of estrus was less in trial 2 than in trial 1.

Administration, Intravaginal↗
PubMed2002

Observations on experimental colonisation of mice by ureaplasmas of human origin.

Three serovars (5, 8 and 10) of Ureaplasma urealyticum were inoculated intravaginally into groups of oestradiol-treated young adult BALB/c strain mice. Hormone treatment was essential for vaginal colonisation. The proportion of mice colonised initially and the persistence of colonisation were different with the three serovars; half of those given serovar 8 were still colonised after 84 days. A strain of serovar 5 after a further 50 subcultures in vitro was a little less persistent than it was before such subculture, but not in a way to suggest that subculturing was the main reason for differences in the behaviour of the serovars. At autopsy of six mice that were still colonised vaginally 158 days after inoculation of serovar 8, spread to the upper genital tract was shown to have occurred in three of them and dissemination to the liver and kidney in one. Compared with immunocompetent mice of strain CB20, such dissemination was not a feature in genetically related mice with severe combined immunodeficiency. This is not in keeping with the situation in hypogammaglobulinaemic patients in whom ureaplasmas and other mycoplasmas are known to disseminate. However, differences in the proportion of immunocompetent mice colonised or in ureaplasmal persistence with different serovars may act as a marker for differences in human pathogenicity and is worthy of further study.

Administration, Intravaginal↗
PubMed2001

The application of a plasmid DNA encoding IFN-alpha 1 postinfection enhances cumulative survival of herpes simplex virus type 2 vaginally infected mice.

Using a hormonally induced susceptibility mouse model to investigate vaginal HSV type 2 (HSV-2) infection, a study was undertaken to determine the efficacy of a plasmid DNA encoding IFN-alpha1 introduced into the vaginal lumen postinfection (PI). Mice infected with HSV-2 intravaginally and treated intravaginally 24 h later with 100 microg DNA encoding IFN-alpha1 showed enhanced survival (10/15) in comparison to mice treated with 100 microg plasmid DNA vector alone (3/10) or vehicle (4/27). In contrast, mice receiving recombinant IFN-alphaA (5-500 U/vagina) 24 h PI showed no significant survival in comparison to the vehicle (saline)-treated group. The protective effect was time dependent in that mice receiving the IFN-alpha1 transgene 48 h PI succumbed at a rate similar to the plasmid DNA vector-treated group. The increase in cumulative survival elicited by the transgene corresponded with a reduction in viral replication and Ag expressed in the vaginal epithelium early (i.e., 3 days PI) during acute infection and replicating virus recovered in the spinal cord day 7 PI. By day 7 PI, HSV-2 glycoprotein B transcript expression was no longer detectable in vaginal tissue from the IFN-alpha1 transgene-treated group (0/8) compared with levels expressed in plasmid vector-treated controls (4/6 mice surveyed were positive). Collectively, these results suggest the application of DNA encoding type I IFN is an effective and alternative approach to currently prescribed therapies in controlling vaginal HSV-2 infection by antagonizing viral replication.

Acute Disease↗
PubMed2001

Evaluation of a low-dose nonoxynol-9 gel for the prevention of sexually transmitted diseases: a randomized clinical trial.

BACKGROUND: Low-dose nonoxynol-9 products have a potential advantage of reduced toxicity. However, little is known about their efficacy in reducing the incidence of sexually transmitted diseases (STDs). GOAL: To determine the effect that an intravaginal gel containing 52.5 mg of nonoxynol-9 has on the acquisition of STDs in a cohort of HIV-1-seronegative female sex workers in Mombasa, Kenya. STUDY DESIGN: A randomized double-blind placebo controlled trial was performed. RESULTS: In this study, 139 women were randomized to the nonoxynol-9 group and 139 to the placebo group. No significant differences were found between the two study groups in terms of safety outcomes and reported symptoms, except for a lower incidence of vaginal erythema in the nonoxynol-9 group. There was a significantly higher incidence of gonorrhea in the nonoxynol-9 group than in the placebo group. No significant differences were observed between the groups for acquisition of Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1, although the statistical power to detect differences for some of these STDs was limited. CONCLUSIONS: In this randomized placebo-controlled trial of a low-dose nonoxynol-9 gel, a significantly higher incidence of gonorrhea was found in the nonoxynol-9 group, but no significant differences between the groups were found for Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1.

Administration, Intravaginal↗
PubMed1998

The use of two estrogen preparations (a combined contraceptive pill versus conjugated estrogen cream) intravaginally to treat urogenital symptoms in postmenopausal Thai women: a comparative study.

OBJECTIVE: To determine whether the combined contraceptive pill used intravaginally was as effective as the standard conjugated estrogen cream for the treatment of urogenital symptoms in postmenopausal Thai women. SUBJECTS AND METHODS: In a randomized clinical trial, 40 postmenopausal women with urogenital symptoms were randomly allocated to two treatment groups for 8 weeks. The first group (n = 20) received a combined contraceptive pill by the vaginal route, one tablet per week at bedtime for 8 weeks. Each tablet contained 250 microg levonorgestrel plus 30 microg ethinyl estradiol. The second group (n = 20) was given 1 gm of an intravaginal conjugated estrogen cream at bedtime, three times in the first week, twice in the second week, and then once a week for the next 6 weeks (1 gram of conjugated estrogen cream contained 0.625 mg conjugated equine estrogens). Subjects were questioned about their urogenital symptoms, and vaginal cytologic smears, vaginal bacterial cultures, and urine cultures were performed before treatment and after 2, 4, and 8 weeks of therapy. RESULTS: The vaginal pH and the proportion of the fecal type bacteria decreased in both groups, with no statistically significant difference between the groups. The karyopyknotic index and the maturation index were improved during treatment in both groups. An increase in the proportion of lactobacilli were recorded in both groups after therapy, with no significant difference between the two groups. No significant changes were observed in urinary bacteria. The therapy (combined contraceptive pill and estrogen cream) had a marked effect on urogenital symptoms (vaginal dryness, dyspareunia, urinary frequency, and urinary urgency), with impressive improvement comparably in both groups. CONCLUSIONS: A combined contraceptive tablet administered vaginally once a week can alleviate urogenital symptoms in Thai postmenopausal women as effectively as the vaginal estrogen cream. However, the pills are much less expensive and are easily obtained in developing countries.

Administration, Intravaginal↗
PubMed2002

Second trimester abortion by laminaria followed by vaginal misoprostol or intrauterine prostaglandin F2alpha: a randomized trial.

Intra-amniotic injection, as well as intravaginal application of prostaglandins, have been used to terminate second trimester pregnancies. There is as yet no consensus as to the most efficient protocol of such late abortions. Our goal was to compare the efficacy of intra-amniotic injection of prostaglandin F2 alpha (PGF2alpha) and intravaginal application of misoprostol in terminating second trimester pregnancies after pretreatment with intracervical laminaria. Women with live fetuses and requesting second trimester abortions were randomized into two groups. Eighteen hours following the insertion of intracervical laminaria, women were treated with either intra-amniotic injection of 40 mg PGF2alpha, or 12 hourly doses (to a maximum of 4 doses) of 200 mcg misoprostol. Fifty women were randomly assigned to each group. Failure to abort within 24 h of initiation of treatment occurred in 6 patients (12%) in the misoprostol group and 14 (28%) of the PGF2alpha group (p = 0.04). Mean time of induction of pharmacologic treatment to abortion was 13.6 h in the misoprostol group and 10.7 h in the PGF2alpha group (p = 0.03). The mean number of analgesic injections given were 0.8 in the misoprostol group and 1.6 in the PGF2alpha group (p = 0.0001). Only the method of abortion was predictive of abortion success and not other variables such as patient age, gestational age, gravidity, or parity. Following intracervical laminaria, vaginal misoprostol has been found to be more effective and less painful, compared with intra-amniotic PGF2alpha, for the termination of second trimester pregnancies with live fetuses.

Abortifacient Agents, Nonsteroidal↗
PubMed1996

Human natural yeast killer toxin-like candidacidal antibodies.

A murine mAb (mAbKT4, IgG1) that neutralized in vitro the anti-Candida activity of a killer toxic (KT) from the yeast Pichia anomala acted as an idiotypic (Id) vaccine in eliciting anti-Id Abs with toxin-like activity (KT-IdAb) in a rat vaginitis model. In this study, we demonstrate that intravaginal or intragastric inoculations of Candida albicans bearing a receptor for the toxin was able to recall KT-IdAb production in the vagina of the animals primarily immunized with mAbKT4 and also to elicit by themselves an Ab that functionally mimicked the KT (KTAb). Anti-Id-like, KT-like Abs were also consistently found in the vaginal fluid of human vaginitis patients who were infected by Candida but who had never been exposed to the Id vaccine. These Abs were as candidacidal in vitro as those raised in rat vagina by the Id vaccination, and, likewise, their cytocidal effect was totally neutralized by previous reaction with mAbKT4. Importantly, they were also able to confer a significant anticandidal protection in the rat vaginitis model, comparable to that achievable by KT-IdAb passively transferred to naive rats from Id-vaccinated animals. Thus, candidacidal Abs representing the internal image of a yeast KT are part of the Ab repertoire that follows infection or immunization with Candida. It is speculated that the host's immune system response may exploit the KT receptor of microbial pathogens to produce microbicidal Abs, possibly mirroring competition events among microorganisms in natural habitats.

Administration, Intravaginal↗
PubMed2005

Induction of estrus in non-lactating dairy goats with different estrous synchrony protocols.

The objective of this study was to evaluate two protocols of estrous synchronization in non-lactating Toggenburg goats. Nineteen goats were allocated, according to body condition score and weight, into two groups (A and B) and evaluated utilizing two treatments (T1 and T2). Animals in the T1 and T2 groups received an intravaginal sponge (day 0) containing 60 mg medroxyprogesterone acetate for 6 and 9 days, respectively, plus 200 IU equine chorionic gonadotrophin (eCG) and 22.5 microg cloprostenol 24 h before sponge removal. Females were bred only at the second estrus and received 22.5 microg cloprostenol 7 days later to prevent pregnancy. Percentages of animals in estrus did not differ (P > 0.05) between T1 (89.5%) and T2 (84.2%). From 33 females in estrus (T1 + T2), 28 (84.8%), 2 (6.1%), and 3 (9.1%) were identified in estrus at 06:00, 12:00 and 18:00 h, respectively. Additionally, 6 (18.2%), 0 (0.0%) and 27 (81.8%) were no longer detected to be on estrus at 06:00, 12:00 and 18:00 h, respectively. Interval from sponge removal and the onset of estrus (IE) did not differ (P > 0.05) between T1 (46.1 +/- 15.0 h) and T2 (53.6 +/- 16.1 h). Duration of estrus did not differ (P > 0.05) between T1 (30.0 +/- 12.0 h) and T2 (27.2 +/- 11.2 h). Both protocols were effective in inducing estrus in non-lactating goats. The onset and end of the estrus relative to hour of the day should be considered in estrous detection, natural breeding, and artificial insemination in goats.

Administration, Intravaginal↗
PubMed1995

An ultrasonographic study of bovine cystic ovarian disease and its treatment.

This study assessed the value of ultrasonography in characterising bovine cystic ovaries and monitoring their responses to different treatments. Thirteen cows were diagnosed by ultrasonography as having luteinised ovarian cysts and seven were diagnosed as having follicular ovarian cysts. Six of the former were treated with prostaglandin, four with a progesterone intravaginal device (PRID) and three with gonadotrophin-releasing hormone (Gn-RH); five of the latter were treated with Gn-RH and two with a PRID. All the animals were re-examined by ultrasound and blood was collected for the measurement of plasma progesterone concentration at intervals until oestrus. The treatment of the luteinised cysts with prostaglandin caused marked decreases in size and plasma progesterone concentration and altered their echotexture within two to four days; oestrus occurred within three to four days. In two of the cows treated with a PRID the cysts regressed within one to two weeks but the other two cows required supplementary treatment with prostaglandin; oestrus and ovulation were observed only after the cysts collapsed. Gn-RH stimulated oestrus and ovulation within three to four days but the cysts did not collapse until much later. The treatment of the follicular cysts with Gn-RH or a PRID caused fresh ovulation and the formation of a corpus luteum but had little immediate effect upon the cyst. The plasma progesterone concentrations in some of the cows with either follicular or luteal cysts were similar on the day of treatment and were therefore of little value in differentiating the types of cyst.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed1992

Superovulation and egg recovery in goats in the tropics.

The superovulatory response to gonadotrophin treatment during different months of the year was investigated in Kambing kacang goats, a tropical breed, in Malaysia. Sixty-three cycling does, fitted with progesterone impregnated intravaginal sponges for 17 days, received two days before sponge withdrawal, an intramuscular injection of either 10, 15 or 20 mg of follicle stimulating hormone (FSH) or 500, 1000 or 1500 iu of equine chorionic gonadotrophin (eCG). The dose of FSH was divided into four decreasing daily doses and each daily dose was subdivided into two and administered at 07.00 and 19.00. Fifty-four does detected in oestrus were mated with fertile bucks. The ovarian response was determined by laparoscopy and eggs were recovered surgically five or six days after oestrus. The ovulatory response (mean +/- standard deviation) based on corpora lutea was higher in the FSH (13.4 +/- 8.4 corpora lutea per doe, n = 20) than the eCG-treated groups (6.4 +/- 5.1 corpora lutea per doe, n = 25) but the difference was not significant (P greater than 0.05). Does responded to gonadotrophins throughout the year with more than 50 per cent of does responding during the rainy months compared with less than 35 per cent responding during the dry months. This difference was statistically significant (P less than 0.05). Egg recovery was better in the FSH (6.8 +/- 5.3 per doe, n = 20) than the eCG groups (3.0 +/- 3.8 per doe, n = 21) but the difference was not significant (P greater than 0.05).

Administration, Intravaginal↗
PubMed2002

Misoprostol versus low-dose oxytocin for cervical ripening: a prospective, randomized, double-masked trial.

OBJECTIVE: A variety of cervical ripening agents exist, yet none is ideal. We performed a prospective, randomized, double-masked comparison of low-dose minimal-escalation oxytocin to misoprostol in a predominantly high-risk population. STUDY DESIGN: Patients were allocated prospectively in a double-masked, randomized, stratified basis by an investigational pharmacist between December 1996 and December 2000 to receive either active intravenous oxytocin and placebo intravaginal misoprostol or intravenous placebo oxytocin and 50 microg of active intravaginal misoprostol. The infusion rate of oxytocin was increased from 1 to 4 mU/min; misoprostol (25 microg) was repeated at 4 hourly intervals if there were <3 uterine contractions per 10-minute interval. RESULTS: Demographic characteristics did not differ between study groups nor did the indications for induction. Overall, the interval to delivery was less in the misoprostol group; however, vaginal delivery occurred in 61% versus 66% (not significant) of patients in the misoprostol versus oxytocin group. Indication for cesarean delivery in the misoprostol group was fetal intolerance to labor in 27% compared with 8% in the oxytocin groups (P <.05), whereas labor abnormalities were more commonly the cause in the oxytocin group versus misoprostol (26% vs 10%, P <.05). The proportion of patients was similar in each group overall and when evaluated on the basis of parity and when delivery was compared at 12, 24, and 36 hours after the initiation of cervical priming. CONCLUSION: Our data indicate that misoprostol and low-dose minimal-escalation oxytocin appear to be equally effective for cervical priming. Low-dose oxytocin may have a preferential role in the high-risk parturient whose fetus is at increased risk for fetal intolerance to labor

Administration, Intravaginal↗
PubMed2005

The efficacy and safety of a single dose of Clindesse vaginal cream versus a seven-dose regimen of Cleocin vaginal cream in patients with bacterial vaginosis.

OBJECTIVE: To determine whether a single dose of Clindesse vaginal cream is comparable in efficacy and safety to Cleocin vaginal cream administered once daily for 7 days in the treatment of bacterial vaginosis. STUDY DESIGN: This multicenter, randomized, single-blind, parallel-group study enrolled 540 patients with BV infections. Treatment consisted of either a single intravaginal dose of Clindesse or 7 daily doses of Cleocin. Efficacy and safety were assessed 21-30 days after the start of treatment. The efficacy endpoints were Investigator Cure, Clinical Cure (a composite of all 4 Amsel's criteria and Investigator Cure), Nugent Cure (Nugent score < 4), and Therapeutic Cure (a composite of Clinical Cure and Nugent Cure). Resolution of individual Amsel's criteria was also evaluated. Treatment-emergent adverse events were monitored throughout the study. RESULTS: There were no significant differences in cure rates between the Clindesse and Cleocin treatment groups in Investigator Cure (P=0.702), Clinical Cure (P=0.945), Nugent Cure (P=0.788), or Therapeutic Cure (P=0.572). Results were also similar for 3 of 4 and 2 of 4 Amsel's criteria and for each individual Amsel's criterion (all P-values >0.200). Ninety-five percent confidence intervals for each endpoint were consistent with equivalence between the 2 products. There was no significant difference between the treatment groups in the incidence of treatment-emergent adverse events (P=0.386). CONCLUSIONS: A single dose of Clindesse vaginal cream is equivalent in safety and efficacy to a 7-dose regimen of Cleocin vaginal cream in the treatment of bacterial vaginosis. This represents a significant advance in the treatment of bacterial vaginosis.

Administration, Intravaginal↗
PubMed1994

[Misoprostol--a PGE1 analog for induction of labor at term: comparative and randomized study with oxytocin].

The efficacy of misoprostol (a PGE1 analog) for induction of labor at term was compared with oxytocin by means of an open and randomized study in 153 pregnant women. A vaginal tablet containing 50 mcg of misoprostol was placed intravaginally in 78 women, the remaining 75 patients received i.v. oxytocin (2-32 mU/min). Bishop's score at the entry of the trial was similar in both groups. Delivery within 24 hours was achieved in 85.7% of the patients induced with misoprostol and in 64% of the patients infused with oxytocin (p < 0.05). Mean induction to delivery interval was significantly shorter in the misoprostol group (552 +/- 211 min; mean =SD) in comparison with that of the oxytocin group (745 +/- 292 min; mean +/- SD) (p < 0.05). The probability of still being pregnant at 24 hours (Life table analysis) was 14% (misoprostol group) and 26% (oxitocyn group). The difference was also statistically significant (p < 0.01). No undesirable side effects were observed in any of the patients, however, polisystoly (> 5 contractions in 10 min) was more frequently observed in the patients induced with misoprostol (24.6% vs 13.3%; p = NS). Cesarean section rate was higher in the oxytocin-induced patients (25.3%) than in the misoprostol-induced women (3.8%) (p < 0.05). The main cause of cesarean section was failure to progress in labor in both groups of patients. Neonatal outcome was good in both groups and there were no differences with respect to birthweight or to Apgar scores.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed2001

Induction of labour with a viable infant: a randomised clinical trial comparing intravaginal misoprostol and intravaginal dinoprostone.

OBJECTIVE: To compare the efficacy and safety of vaginal misoprostol (50 microg) with vaginal dinoprostone. DESIGN: Double-blind randomised trial. SETTING: Obstetrics Department, Poissy Hospital, France. PARTICIPANTS: 370 patients with medical indications for induction of labour. OUTCOME MEASURES: Vaginal deliveries within 24 hours, as well as time to vaginal deliveries, caesarean rates, costs, and fetal, neonatal and maternal condition. RESULTS: Compared with vaginal dinoprostone, vaginal misoprostol resulted in greater efficacy in several areas: vaginal delivery within 24 hours; time to vaginal delivery; and vaginal delivery within 12 hours. There was a non-significant increase in the caesarean section rate for fetal distress in the misoprostol group, but fewer caesarean sections for failed induction. Fetal tolerance was similar in the two groups, although significantly more neonates had a cord pH <7.20 and (non-significantly) none had meconium stained amniotic fluid in the misoprostol group. The incidence of poor neonatal outcome was similar in both groups. Subgroup analysis by indication for induction showed that the higher rates of arterial cord pH <7.20 and of meconium-stained amniotic fluid with misoprostol persisted only in possible fetal compromise. Poor neonatal outcome was less frequent in the misoprostol group in cases of induction for non-fetal indications. CONCLUSIONS: Vaginal misoprostol resulted in successful and earlier induction of labour more often than dinoprostone, but the safety of misoprostol raises some concern in potentially compromised infants. Misoprostol should be preferred to dinoprostone in cases of induction for non-fetal indications.

Administration, Intravaginal↗
PubMed1995

Induction of labour with intravaginal misoprostol in the second and third trimesters of pregnancy.

OBJECTIVE: To confirm the effectiveness of misoprostol as a labour-induction agent. DESIGN AND SETTING: One hundred and ten consecutive second- and third-trimester hospital patients. Patients with intra-uterine deaths (group A) received 100 micrograms misoprostol 4-hourly and those with live fetuses (group B) 50 micrograms misoprostol 4-hourly until labour commenced. SUBJECTS: Forty-eight patients in group A (group A1 second trimester 27, group A2 third trimester 21); 62 mainly hypertensive patients in group B. OUTCOME MEASURES: These were the amount of misoprostol required to induce labour; duration of induction and labour; success and completeness of vaginal delivery; neonatal outcome; and cost. RESULTS: In group A1, labour was successfully induced in 21/27 (77.8%) patients with 157.4 micrograms misoprostol; and in 19/21 (90.5%) patients in group A2 with 128.9 micrograms misoprostol. Cost per successful induction was R0.55 and R0.44 respectively. Mean induction times were 13.2 hours and 13.4 hours respectively. All patients delivered vaginally but incompletely in 7/21 group A1 and 1/19 group A2 patients. In group A2, the mean duration of labour was 5.97 hours. In group B induction was successful in 51/62 (82%) with 95.1 micrograms of misoprostol; the mean cost was R0,32. Twelve out of 51 (23%) received oxytocin and 44/51 delivered vaginally. Mean duration of induction was 11.4 hours and of labour 5.4 hours. Two babies had low Apgar scores. There were two stillbirths (perinatal mortality rate 39.2/1000), both apparently unrelated to misoprostol. CONCLUSIONS: Misoprostol is an effective, easy to use, apparently safe and cheap drug for the induction of labour.

Administration, Intravaginal↗
PubMed2006

Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide.

TMC 120 (Dapivirine) is a potent non-nucleoside reverse transcriptase inhibitor that is presently being developed as a vaginal HIV microbicide. To date, most vaginal microbicides under clinical investigation have been formulated as single-dose semi-solid gels, designed for application to the vagina before each act of intercourse. However, a clear rationale exists for providing long-term, controlled release of vaginal microbicides in order to afford continuous protection against heterosexually transmitted HIV infection and to improve user compliance. In this study we report on the incorporation of various pharmaceutical excipients into TMC 120 silicone, reservoir-type intravaginal rings (IVRs) in order to modify the controlled release characteristics of the microbicide. The results demonstrate that TMC 120 is released in zero-order fashion from the rings over a 28-day period and that release parameters could be modified by the inclusion of release-modifying excipients in the IVR. The hydrophobic liquid excipient isopropyl myristate had little effect on steady-state daily release rates, but did increase the magnitude and duration of burst release in proportion to excipient loading in the IVR. By comparison, the hydrophobic liquid poly(dimethylsiloxane) had little effect on TMC 120 release parameters. A hydrophilic excipient, lactose, had the surprising effect of decreasing TMC 120 burst release while increasing the apparent steady-state daily release in a concentration-dependent manner. Based on previous cell culture data and vaginal physiology, TMC120 is released from the various ring formulations in amounts potentially capable of maintaining a protective vaginal concentration. It is further predicted that the observed release rates may be maintained for at least a period of 1 year from a single ring device. TMC 120 release profiles and the mechanical properties of rings could be modified by the physicochemical nature of hydrophobic and hydrophilic excipients incorporated into the IVRs.

Administration, Intravaginal↗
PubMed1996

Double-blind comparison of 2.5 and 5.0 mg of prostaglandin E2 gel for preinduction cervical ripening.

OBJECTIVE: To compare the effectiveness and safety of 2.5 vs. 5.0 mg of prostaglandin E2 (PGE2) gel for preinduction cervical ripening. STUDY DESIGN: Patients presenting for induction of labor with an unfavorable Bishop score (< or 4) were assigned randomly, in a double-blind manner, to receive either 2.5 or 5.0 mg of PGE2 gel intravaginally. A repeat Bishop score was determined in four to six hours, and if the score was still unfavorable, the same dose of gel was administered a second time. All patients returned within 12 hours for induction of labor. RESULTS: A total of 119 patients received PGE2 gel, 55 in the 2.5-mg group and 64 in the 5.0-mg group. Both groups were similar with respect to age, parity, race, indication for induction and preinduction Bishop score. Both doses of PGE2 gel were safe and effective. The need for additional doses of gel, the need for and duration of oxytocin use, and the duration of labor were similar in both groups. More infants whose mothers received the 5.0-mg dose had one-minute Apgar scores < 7 (P = .027). No significant difference in five-minute Apgar scores was noted. Cesarean delivery for failed induction was uncommon, occurring in 3.6% of patients who received 2.5 mg and in 4.7% of patients who received 5.0 mg of PGE2 gel (P = NS). Finally, the incidence of hyperstimulation was 3.6% in the 2.5-mg group and 1.6% in the 5.0-mg group (P = NS). CONCLUSION: A 5-mg dose of PGE2 gel was neither more effective nor associated with more side effects than the more commonly used 2.5-mg dose.

Administration, Intravaginal↗
PubMed2002

Intravaginal misoprostol vs. expectant management in premature rupture of membranes with low Bishop scores at term.

OBJECTIVES: To evaluate the efficacy of vaginal misoprostol for cervical ripening and labor induction in premature rupture of membranes (PROM) cases with low Bishop scores at term. METHODS: Sixty-two PROM cases who fulfilled the criteria of 36 weeks of completed gestation, not in active labor, singleton pregnancy with vertex presentation, normal fetal heart rate reactivity, amniotic fluid index >5 cm and Bishop score <5, consented to participate in the study. Thirty-one of the cases were included in study group and a 50-microg misoprostol tablet was placed in the posterior vaginal fornix. Another 31 cases were included in control group and managed expectantly. Treatment success was defined as an interval from membrane rupture to delivery of <24 h. RESULTS: The mean admittance-delivery interval was significantly shorter in the study group (8.68+/-4.40 h) compared with the control group (26.22+/-18.98 h, P=0.001) and the mean interval from membrane rupture to delivery were also significantly shorter in the study group (19.37+/-7.20 h) than the control group (33.05+/-20.85 h, P=0.001). Oxytocin necessity was significantly lower in the study group than the control group (45.2% vs. 100%, P=0.00051). Tachysystole occurred more frequently in the study group (8 cases, 25.8% vs. 2 cases, 6.5%, P=0.038). There were no difference between two groups with regard to birth weights, 1- and 5-min Apgar scores and the need for neonatal intensive care unit. CONCLUSIONS: It is effective, safe and economic to use misoprostol vaginally in PROM cases with low Bishop scores at term.

Administration, Intravaginal↗