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PubMed2004

Control, communication and monitoring of intravaginal drug delivery in dairy cows.

We present the design of an electronically controlled drug delivery system. The intravaginally located device is a low-invasive platform that can measure and react inside the cow vagina while providing external control and monitoring ability. The electronics manufactured from off the shelf components occupies 16 mL of a Theratron syringe. A microcontroller reads and logs sensor data and controls a gascell. The generated gas pressure propels the syringe piston and releases the formulation. A two way radio link allows communication between other devices or a base station. Proof of principle experiments confirm variable-rate, arbitrary profile drug delivery qualified by internal sensors. A total volume of 30 mL was dispensed over a 7-day-period with a volume error of +/- 1 mL or +/- 7% for larger volumes. Delivery was controlled or overridden via the wireless link, and proximity to other devices was detected and recorded. The results suggest that temperature and activity sensing or social grouping determined via proximity can be used to detect oestrus and trigger appropriate responses.

Administration, Intravaginal↗
PubMed2004

Progesterone supplementation during the early fetal period reduces pregnancy loss in high-yielding dairy cattle.

It was hypothesized that sub-optimal progesterone concentrations during the late embryo and early fetal period may act to compromise conceptus development in dairy cattle. The aim of the present study was to test this hypothesis by supplementing pregnant cows with exogenous progesterone following pregnancy diagnosis. The study population consisted of 1098 pregnant lactating cows. Pregnancy was diagnosed by transrectal ultrasonography between 36 and 42 days after insemination. Animals found to be pregnant were randomly assigned to the Control (untreated cows, n = 549) or Treatment (n = 549) groups. Cows in group Treatment were fitted at pregnancy diagnosis with a progesterone releasing intravaginal device (PRID) containing 1.55 g of progesterone, for 28 days. Cows were then subjected to a further diagnosis by palpation per rectum on Day 90 of gestation. Pregnancy loss was registered in 95 (8.7%) cows on Day 90 of pregnancy: 66 (12%) in group Control and 29 (5.3%) in group Treatment. Logistic regression analysis indicated that there were no significant effects of herd, bull, milk production, service number, days in milk at pregnancy and lactation number. Based on the odds ratio, treated cows were 2.4 (1/0.41) times less likely to miscarry, whereas the risk of pregnancy loss was 1.6 times higher in cows that became pregnant during the warm period in comparison to the cool period. These results support the hypothesis that sub-optimal progesterone concentrations in high producer dairy cows may compromise conceptus development. Under these conditions, intra-vaginal progesterone supplementation has the potential to reduce the incidence of pregnancy loss during the early fetal period.

Abortion, Veterinary↗
PubMed1999

A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles.

A simple programmed thaw cycle is described, during which the endometrium is prepared with oral oestradiol, followed by a natural progesterone source. This method involves minimal blood tests and uses inexpensive medications. Originally, an i.m. progesterone-in-oil preparation was used. Although highly successful in achieving high serum progesterone concentrations, the daily injections of the oily compound were found to be problematic from the patients' perspective. To examine the possibility of replacing the injectable progesterone with a vaginal preparation we conducted a prospective randomized study of 1 year's duration, during which time 170 and 184 thawing cycles were done with injectable and vaginal progesterone respectively. Although the progesterone blood concentrations obtained with the injectable preparation were more than twice those obtained with the vaginal progesterone, the clinical pregnancy rates (defined as percentage thawing cycles with gestational sac(s)/embryo transfer as demonstrated on ultrasound, 4 weeks after embryo transfer) were similar for both groups (15.9 and 16.8% respectively). Implantation and abortion rates were also comparable. These results agree with previous reports of higher uterine progesterone concentrations after the vaginal application. We conclude that the combination of oral oestradiol and vaginal progesterone is an effective, simple and inexpensive approach for programmed thaw cycles.

Administration, Intravaginal↗
PubMed2004

17 alpha-hydroxyprogesterone caproate versus intravaginal progesterone in IVF-embryo transfer cycles: a prospective randomized study.

One of the main issues in the management of IVF and embryo transfer techniques is to ensure adequate concentrations of progesterone. The aim of this prospective, randomized study was to compare the effectiveness of 17 alpha -hydroxyprogesterone caproate (17-HPC) administered intramuscularly and intra-vaginal progesterone in gel in luteal phase support in patients undergoing IVF-embryo transfer cycles. A total of 320 patients were randomly treated with either 17-HPC (341 mg i. m. every 3 days) or progesterone vaginal gel (90 mg daily). The inclusion criteria were the use of gonadotrophin-releasing hormone down-regulation and age <40 years. The outcome of IVF in both study groups was evaluated for implantation rate, biochemical pregnancy, clinical pregnancy, miscarriage, and ongoing pregnancy rate. The results of this study showed that 17-HPC conferred more benefit to IVF-embryo transfer cycles compared with intra-vaginal progesterone, as demonstrated by the results of most of the main outcome parameters considered. The data showed that 17-HPC administered every 3 days appears to be more effective in providing luteal support in comparison to intra-vaginal progesterone.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed2006

Pharmacokinetics of a controlled-release misoprostol vaginal insert at term.

OBJECTIVE: The objective of this investigation was to report the pharmacokinetic properties of misoprostol administered intravaginally to women at term via a controlled-release hydrogel polymer insert. METHODS: This open-label, dose escalation trial consisted of 31 nulliparous women at term who were treated intravaginally in cohorts of six with inserts containing reservoirs from 25 through 300 microg (7 at 200 microg) of misoprostol. Inserts remained intravaginally until the patient went into labor, developed adverse events, or completed 24 hours of treatment. Complete data about residual drug in the inserts and plasma concentrations of misoprostol acid were gathered for 27 and 25 patients, respectively. RESULTS: Misoprostol was released at a constant rate (5.1% total dose per hour) with the amount absorbed being directly proportional to the dose reservoir. For the 25-, 50-, 100-, 200-, and 300-microg reservoir doses, the maximum median plasma concentrations were 6.4, 11.3, 21.7, 40.8, and 74.2 pg/mL, respectively, and the area under the curve until drug removal was 39, 117, 223, 269, and 477 pg x h/mL. Regardless of dose, the peak plasma concentration occurred at approximately 7 hours after insertion and the elimination half-life of the misoprostol acid was 0.55 hours (95% confidence interval, 0.36 to 1.32 hours). CONCLUSIONS: Misoprostol is released from the vaginal insert in a controlled manner and is eliminated rapidly after removal. Pharmacokinetic parameters are proportional to the reservoir dose.

Administration, Intravaginal↗
PubMed1990

Secretory immune responses in mouse vaginal fluid after pelvic, parenteral or vaginal immunization.

Intravaginal immunization causes IgA responses in vaginal fluid, but so far lymphoid nodules in mouse vaginal mucosa have not been detected. The present study was therefore designed to test the hypothesis that IgA responses in the female reproductive tract may be generated in the regional iliac lymph nodes. Two, non-mucosal sites were identified in the female mouse pelvis, the subserous and presacral spaces, from which lymph drains mainly to the iliac nodes. Immunization at these pelvic sites with horse ferritin adsorbed to aluminum hydroxide (AH) caused much higher IgA and IgG titres in vaginal fluid than intravaginal immunization; moreover, the pelvic immunizations caused significantly higher and better sustained IgA titres in vaginal fluid than subcutaneous immunization near the scapulae or in the perineum, while IgG titres in vaginal fluid were similar in these groups. Additional mice were immunized with ferritin subcutaneously near the scapulae or in the presacral pelvic space using dimethyl dioctadecyl ammonium bromide (DDA), AH plus muramyl dipeptide, or the Ribi adjuvant system as adjuvants. Pelvic immunization caused higher IgA titres in vaginal fluid than subcutaneous immunization in each case. The IgA response stimulated by DDA was similar to that produced by AH but higher than the responses caused by the other two adjuvants, while IgG titres were similar with all four adjuvants in both sites. The results suggest that non-mucosal, pelvic immunization is particularly effective in stimulating IgA responses in the female reproductive tract. The observation is consistent with the possibility that the iliac lymph nodes may play a role in the development of IgA responses in the reproductive tract.

Adjuvants, Immunologic↗
PubMed2004

Efficacy of genital T cell responses to herpes simplex virus type 2 resulting from immunization of the nasal mucosa.

Intravaginal (ivag) or intranasal (i.n.) immunization of C57BL/6J (B6) mice with a thymidine kinase-deficient strain (tk-) of herpes simplex virus type 2 (HSV-2) resulted in comparable protection of the genital epithelium and sensory ganglia against HSV-2 challenge. In contrast, protection of these sites was much reduced in i.n.-immunized compared to ivag-immunized B cell-deficient microMT mice. Fewer HSV-specific T cells were detected in the genital epithelium of i.n.-immunized compared to ivag-immunized microMT mice after HSV-2 challenge. Passive transfer of HSV-specific serum to immune microMT mice restored protection of these sites against HSV-2 challenge. These results suggest that protection of genital and neuronal sites may be conferred by i.n. immunization but may be more dependent on antibody-dependent mechanisms than the protection resulting from genital immunization. These results have implications for immunization strategies to elicit high levels of cell-mediated protection of the genital tract and sensory ganglia.

Administration, Intranasal↗
PubMed2003

Effect of vaginal pH on efficacy of the controlled-release dinoprostone vaginal insert for cervical ripening/labor induction.

OBJECTIVE: To evaluate whether vaginal pH alters the efficacy of the controlled-release dinoprostone vaginal insert (Cervidil) for cervical ripening/labor induction. METHODS: Thirty-four women with an unfavorable cervix undergoing labor induction were enrolled in this prospective, double-blind investigation. Vaginal pH and Bishop score assessments were made by an independent examiner. All women received preinduction with the dinoprostone vaginal insert 10 mg intravaginally for 12 h. Twelve hours later, oxytocin induction initiated according to the standardized protocol and outcome data were collected. RESULTS: Mean (+/- SD) initial vaginal pH was 4.9 +/- 0.5 for the study cohort. No significant differences were noted between women with a high vaginal pH (> 4.5, n = 18) and those with a low vaginal pH (< or = 4.5, n = 16) with respect to maternal age, parity, gestational age, or initial Bishop score. Similarly, Bishop score change over the preinduction interval (3.2 vs. 3.3), time to active labor (28.6 vs. 24.6 h) and time to delivery (33.7 vs. 31.4 h) were not significantly different between the low and the high pH groups, respectively. Linear regression analysis revealed no significant association between vaginal pH and Bishop score change during the preinduction interval, time to active labor, time to complete dilatation, or time to delivery. CONCLUSION: Vaginal pH does not appear to influence the efficacy of the controlled-released dinoprostone vaginal insert for cervical ripening/labor induction.

Administration, Intravaginal↗
PubMed1990

Double-blind comparison of intravaginal prostaglandin E2 gel and "chip" for preinduction cervical ripening.

The intravaginal application of prostaglandin E2 for preinduction cervical ripening has proved to be advantageous in the management of patients with an unfavorable cervix. The purpose of this double-blind randomized investigation was to compare the efficacy and safety of two methods of prostaglandin E2 delivery. Patients who were to have preinduction cervical ripening because of an unfavorable cervix (Bishop score less than or equal to 4) were randomly assigned to be given a single dose of prostaglandin E2 as either 2.5 mg of gel or a 3.0 mg "chip" intravaginally in a placebo-controlled manner. Sixty-nine patients received the active prostaglandin E2, 34 in the gel group and 35 in the "chip" group. The groups were similar in maternal age, race, parity, gestational age, and initial Bishop score. Both forms of prostaglandin E2 were easy to administer and helpful in priming an unfavorable cervix. The need for, duration of, and maximum dose of oxytocin were similar in both groups. Cesarean delivery because of failed induction occurred in 5 of 35 (14.3%) patients receiving a "chip" and 4 of 34 (11.8%) receiving the gel. However, patients receiving a "chip" experienced a 20% (7/35) incidence of hyperstimulation, compared with 2.9% (1/36) in those receiving the gel (p less than 0.05). The only case requiring immediate cesarean delivery because of intractable uterine hyperstimulation received a "chip." We conclude that both methods were effective for cervical ripening, but the lower incidence of uterine hyperstimulation seen with the gel would suggest that it is preferable to the "chip."

Administration, Intravaginal↗
PubMed2005

Cellulose acetate 1,2-benzenedicarboxylate protects against challenge with pathogenic X4 and R5 simian/human immunodeficiency virus.

OBJECTIVES: To evaluate the protective efficacy of cellulose acetate 1,2-benzenedicarboxylate (CAP) formulated in a glycerol-based gel against infection with CXCR4 (X4) and CCR5 (R5) viruses in the simian/human immunodeficiency virus (SHIV)/rhesus macaque model of HIV-1 transmission. DESIGN: Mucosal infection of non-human primates is a reasonable model for use in the investigation of HIV-1 intervention strategies. METHODS: Rhesus macaques treated with Depo-Provera 5 weeks prior to challenge were inoculated intravaginally twice, over a period of 6 h with mixed inocula of pathogenic X4- and R5-SHIV in the presence or absence of CAP. Plasma viral load, peripheral and mucosal CD4 T cell counts as well as the genotype of the circulating virus were determined. RESULTS: CAP protected seven of ten macaques against transmission of both X4- and R5-SHIV, reaching statistically significant values (P = 0.0256). Delayed and/or reduced virus replication, as well as blunting of peripheral and mucosal CD4 T cell loss was noted in the three macaques that were infected in the CAP treated group compared to those in the placebo group. Further, protection conferred by CAP appeared to be more effective against X4- than R5-SHIV infection. CONCLUSIONS: CAP is protective against highly permissive challenges with X4 and R5 viruses in vivo. Research on further development of this promising compound as a candidate microbicide for the prevention of sexual HIV-1 transmission is therefore warranted.

Administration, Intravaginal↗
PubMed2003

Intravaginal clindamycin to reduce preterm birth in women with abnormal genital tract flora.

OBJECTIVE: To assess the ability of clindamycin vaginal cream to reduce the incidence of preterm birth in women with abnormal genital tract flora in the second trimester of pregnancy. METHODS: This was a randomized, double-blind, placebo-controlled, tricenter study. A total of 409 women with abnormal genital tract flora on Gram stain of vaginal secretions at 13-20 weeks' gestation were randomized to receive a 3-day course of clindamycin vaginal cream or placebo. Those women who still had abnormal vaginal flora 3 weeks later received a 7-day course of the original study drug (ie, either clindamycin vaginal cream or placebo as per original randomization). The primary outcome measure was the incidence of preterm birth. RESULTS: There was a statistically significant reduction in the incidence of preterm birth in the clindamycin vaginal cream group (4%) compared with placebo (10%) (P <.03). Significantly more babies born preterm (63%) required admission to the neonatal intensive care unit compared with term infants (4%) (P <.001). CONCLUSION: A 2% clindamycin vaginal cream, when compared with placebo administered to women with abnormal genital tract flora before 20 weeks' gestation, can reduce the incidence of preterm birth by 60% and hence the need for neonatal intensive care.

Administration, Intravaginal↗
PubMedDate not supplied

The effectiveness of intravaginal misoprostol (Cytotec) in inducing abortion after eleven weeks of pregnancy.

At Maputo Central Hospital in Mozambique, intravaginal misoprostol, a PGE2 methyl-analogue, was used by 169 women whose request for interruption of pregnancy had been approved. The drug was used by women who had completed between 12 and 23 weeks of gestation. The initial dose was 800 micrograms, repeated 24 hours later if abortion had not occurred or was not in progress. The treatment was considered a failure when abortion was not advanced by 48 hours after the initial dose, and curettage was performed in all but one of such cases. During the course of the study, the dosage was successively reduced to 600, 400, and 200 micrograms. Abortion was successfully induced in 154 women (91.1 percent); there were 10 failures (5.9 percent), and five women (3.0 percent) dropped out of the study. The mean time from initial dose to abortion was 14.3 hours. No significant association of success rate and time from dosage to expulsion was found with age, parity, previous abortion, or gestational age. Preventive vacuum aspiration of the uterine cavity was carried out on all subjects.

Abortion, Induced↗
PubMed2001

Evaluation of use of a single intravaginal swab to detect multiple sexually transmitted infections in active-duty military women.

The accuracy and suitability of use of a single intravaginal swab (SIS) for polymerase chain reaction detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and human papillomavirus infection was assessed in a cross-sectional study of 841 active-duty military women. The SIS, compared with standard diagnostic tests, allowed detection of more gonorrhea, more chlamydial infection, and more trichomoniasis. Sensitivity and specificity of SIS detection compared with adjudicated true-positive diagnoses were 95.8% and 97.8%, respectively, for gonorrhea, 94.6% and 99.3% for chlamydial infection, and 92.2% and 98.2% for trichomonal infection. Results with SISs were comparable to those with cervical swabs tested for human papillomavirus. Assay of clinician-collected and self-collected SISs yielded prevalences similar to those of standard diagnostic tests for all sexually transmitted infections. Therefore, the use of SISs is acceptable for the simultaneous diagnosis of multiple sexually transmitted infections and has potential for use as a self-administered diagnostic tool with widespread applicability among women.

Administration, Intravaginal↗
PubMed2000

A comparison of two regimens of intravaginal misoprostol for termination of second trimester pregnancy: a randomized comparative trial.

A prospective randomized trial was conducted in 148 women to compare the efficacy of two regimens of vaginal misoprostol for termination of second trimester pregnancy. Women aged 16-40 years requesting termination of second trimester pregnancy were randomized into two groups. Women in group 1 were given vaginal misoprostol 400 microg every 3 h for a maximum of five doses in 24 h. Women in group 2 were given vaginal misoprostol 400 microg every 6 h for a maximum of three doses in 24 h. If women did not abort in 24 h, the same regimen was repeated. The median induction-abortion interval in group 1 (15.2 h) was significantly shorter (P < 0.01) than that in the group 2 (19.0 h). The percentage of women who achieved successful abortion within 48 h in group 1 (90.5%) was also significantly higher (P < 0.02) than that in group 2 (75.7%). The incidence of fever was more common in group 1 (P = 0.01). It is concluded that the regimen of vaginal misoprostol 400 microg every 3 h with maximum of five doses in 24 h was more effective than the regimen of misoprostol every 6 h in termination of second trimester pregnancy.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Repeated oestrus synchronisation of beef cows with progesterone implants and the effects of a gonadotrophin-releasing hormone agonist at implant insertion.

A group of 97 spring-calving beef cows were initially oestrus synchronised with controlled internal drug release (CIDR) intravaginal progesterone implants inserted for nine days and a prostaglandin injection on day 7. Approximately half the cows were given 10 microg buserelin when the implants were inserted, and they all received a single fixed-time artificial insemination (AI) 56 hours after the withdrawal of the implants. The overall pregnancy rate to the first synchronised AI was 55 per cent, the buserelin-treated cows having a pregnancy rate of 63 per cent compared with 47 per cent in the untreated cows (P>0.05). Sixteen days after the first synchronised AI all the cows were re-implanted with used CIDR implants which were removed five days later, and the cows received a second synchronised AI on days 23 to 24. Cows which received the second AI were implanted with new CIDR devices 16 days later and these were removed after five days and the non-pregnant cows received a third synchronised AI. The pregnancy rates to the second and third synchronised services were 74 per cent and 75 per cent, respectively.

Administration, Intravaginal↗
PubMed1991

Comparative efficacy of intravaginal prostaglandin E2 in the gel and suppository forms for cervical ripening.

Thirty-seven patients admitted for labor induction and presenting with unfavorable cervical features were randomized in a single-blind fashion to receive either 3 mg of prostaglandin E2 in an intravaginal gel or a 2-mg dose in a vaginal suppository. With the aid of previously reported placebo data, the intent was to compare the two dosage forms in terms of their ability to promote cervical ripening, and to see which dosage form was more effective in terms of influencing the overall incidence of cesarean section. The two groups showed a comparable improvement (alpha = 0.05) in cervical condition over that of the placebo group, with the mean Bishop score increasing by 2.0 points in the gel group, 2.5 points in the suppository group, and 0.7 points in the placebo group. As the suppository contained a lower dose of drug than the gel, the data support the concept that the type of drug vehicle and dosage form are important variables affecting product performance. No statistically significant difference in the incidence of cesarean section was noted between the two groups or between either group and placebo. This may be attributable to the small sample size and the relatively high proportion of women diagnosed as having cephalopelvic disproportion/failure to progress. Additional studies are warranted.

Administration, Intravaginal↗
PubMed2003

Concentrations of progesterone in milk of cows administered an intravaginal progesterone insert.

Milk from pregnant cows contains concentrations of progesterone (P4) considered safe for human consumption. The objective of this study was to determine if concentrations of P4 in milk during administration of an intravaginal progesterone insert (CIDR insert) are less than concentrations of P4 in milk associated with pregnancy. Results have implications for human use of milk from cows receiving CIDR inserts. Holstein cows (N = 64; > 40 and < 150 d after calving) were administered 25 mg of PGF2alpha i.m. (study d 0) and 20 cows detected in estrus from 2 to 4 d later were assigned randomly to either control (N = 10; no further treatment) or CIDR insert (N = 10; 1.38 g of P4) inserted on study d 17 (14 +/- 1 d after estrus) and removed 7 d later. Composite milk samples were collected contemporaneously from each of the 20 estrous cycling cows and from 10 pregnant cows (> or = 60 and < or = 220 d of gestation) twice daily from study d 17 to 27. Concentrations of P4 in defatted milk samples were quantified using a validated radioimmunoassay. Mean logs of areas under the curve of concentrations of P4 from the afternoon on study d 17 through the afternoon on study d 27 were 3.05 ng day/ml for control, 3.33 ng day/ml for CIDR insert, and 3.81 ng day/ml for pregnant cows. Therefore, increased P4 due to pregnancy was 0.76 ng day/ml (3.81-3.05), whereas the increase in P4 due to CIDR insert was only 0.28 ng day/ml (3.33-3.05). Applying a 95% confidence interval to 0.28 ng day/ml provided an upper value of 0.70 ng day/ml, lower than the increase due to pregnancy. Because milk from pregnant cows is considered safe for human consumption, it follows that milk from cows administered CIDR inserts should also be considered safe, based on concentrations of P4.

Administration, Intravaginal↗
PubMed1997

Comparative study of intravaginal misoprostol with gemeprost as an abortifacient in second trimester missed abortion.

This prospective, randomized study compared the efficacy of intravaginal misoprostol (Cytotec) and gemeprost (Cervagem) as an abortifacient for intrauterine deaths in second trimester pregnancy. Side-effects, complications and the cost-effectiveness associated with each drug were assessed. 21 out of 25 patients (84%) in the misoprostol group aborted whereas only 17 out of 25 patients (68%) in the gemeprost group aborted within 24 hours after the initiation of therapy. In the misoprostol group, the abortion rate was influenced by the gestational age with 100% abortion rate for those > 17 weeks' gestation compared to 67% for those with a gestational age of 13-16 weeks. Side-effects were rare in either group and no major complications were reported in either group. Misoprostol was definitely more cost-effective compared to gemeprost as the mean cost of inducing an abortion using misoprostol was RM 1.08 whereas that of gemeprost was RM 105. We thus concluded that misoprostol was at least as effective as gemeprost as an abortifacient for intrauterine death in second trimester pregnancy. Moreover, it was less costly, with very few side-effects.

Abortifacient Agents, Nonsteroidal↗