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Intravaginal drug administration offers several advantages over other routes, primarily bypassing the initial stages of metabolism. Additionally, this route has demonstrated both local and systemic effects. Mucoadhesive polymeric systems can be utilized to prevent dose loss due to the mucous barriers and the formation of wet cavities. This study employed various techniques to evaluate the performance and characteristics of a mucoadhesive film composed of HPMC-PEG 400 containing retinyl palmitate and ketorolac molecules. Scanning Electron Microscopy (SEM) was employed to analyze the porous structure of the film. Thermogravimetric Analysis (TGA) was conducted at different temperatures to assess thermal stability. Fourier Transform Infrared Spectroscopy (FTIR) was used to analyze the functional groups and intermolecular interactions between the film and the drug. Swelling and weight loss tests indicated that the film disintegrated within 3–4 days. UV-VIS spectroscopy was used for drug release evaluation based on the Higuchi equation. Additionally, the surface wetting properties were assessed through contact angle measurements. The system’s biocompatibility was confirmed using the MTT assay. Finally, adhesion and glide tests demonstrated the film’s interaction with porcine uterine tissue. This study shows that the HPMC-PEG 400 film containing retinyl palmitate molecules interacts effectively with tissue and could be considered a novel tool for treating damaged epithelial tissues.

PurposeWe aim to provide a comprehensive overview of the role of the vagina as a route for drug delivery and absorption, with a particular focus on the use of vaginal hormonal compounds for the treatment of deep infiltrating symptomatic endometriosis.MethodsA MEDLINE search through PubMed was performed to identify all published studies in English language on vaginal hormonal treatments for symptomatic endometriosis.ResultsMain advantages of the vaginal route include avoidance of the hepatic-first pass metabolic effect, the possibility of using lower therapeutic dosages, and the reduction of side effects compared with the oral administration. Studies on endometriosis treatment mainly focused on the use of vaginal danazol (n = 6) and the contraceptive vaginal ring (n = 2). One pilot study evaluated the efficacy of vaginal anastrozole in women with rectovaginal endometriosis. Most investigations evaluated the vaginal use of hormonal agents in women with deep infiltrating endometriosis/rectovaginal endometriosis. Overall, a substantial amelioration of pelvic pain symptoms associated with endometriosis was observed, particularly of dysmenorrhea. A significant reduction in rectovaginal endometriotic nodule dimensions measured at ultrasound examination was detected by some but not all authors.ConclusionsThe vaginal route represents a scarcely explored modality for drug administration. High local hormonal concentrations might achieve a greater effect on endometriotic lesions compared with alternative routes. Future studies should focus on the use of the vagina for delivering target therapies particularly in patients with deeply infiltrating rectovaginal lesions.

Recombinant lysostaphin has been used for the treatment of cow endometritis and mastitis in China. To our knowledge, no scientific effort has been made to evaluate the efficacy of lysostaphin in sows with clinical endometritis. Lysostaphin, loaded in effervescent tablets that were completely foamed and dissolved within 30 min in the presence of water or body fluids and released active lysostaphin, were administered vaginally on endometritis sows in this study. The clinical recovery, bacterial clearance and reproductive performance of sows with endometritis were investigated. We found that the 400U dosage (400U lysostaphin/pill/time, repeat once on the third day, a total of two times, with 10% oxytetracycline uterine injection as a control) is the most effective treatment. Staphylococcus aureus was the most prevalent finding (34%, n = 188), followed by Streptococcus (32%, n = 181), Escherichia coli (19%, n = 104) and other bacilli (15%, n = 83) before treatment by drugs. Administration of lysostaphin resulted in an extremely significant (p < .01) reduction in S. aureus (0.18 ± 0.25 from 4.57 ± 0.33) and Streptococcus (0.11 ± 0.14 from 3.88 ± 0.29), as well as a significant (p < .05) reduction in E. coli (0.55 ± 0.42 from 3.11 ± 0.14). Mixed infections (83%) were predominant before treatment, in contrast to single infections (61%) after treatment. Large‐scale trials were conducted to verify the clinical efficacy of lysostaphin on sow endometritis. The average cure rate of 400u lysostaphin on sow endometritis(82.5%) was higher than the antibiotic group(72.17%). In addition, our results revealed that intravaginal administration of lysostaphin had no adverse effect on the reproductive performance of sows. Thus, this lysostaphin has potential application value as a new method alternative to antibiotics to treat endometritis in sows. This study examined the effect of intravaginal administration of recombinant lysostaphin on clinical recovery, bacterial clearance, and reproductive performance in sows with clinical endometritis. The outstanding performance of lysostaphin may provide new insights in managing endometritis in sow.

Urogenital infections of bacterial origin have a high incidence among the female population at reproductive age, affecting the fertility. Strains of Escherichia coli can colonize the vagina and replace natural microflora. Lactobacillus the predominant vaginal microorganism in healthy women, maintains the acidic vaginal pH which inhibits pathogenic microorganisms. Studies on Lactobacillus have shown that these can inhibit E. coli growth and vaginal colonization. An alternative therapeutic approach to antimicrobial therapy is to re-establish Lactobacillus in this microbiome through probiotic administration to resurge fertility. Therefore, the aim of the present study was to determine the capability of L. plantarum 2621 strain with probiotic properties, to prevent the vaginal colonization of E. coli causing agglutination of sperms and to evaluate its profertility effect in a murine model. Screened mice were divided into five groups i.e. control group, E. coli group, Lactobacillus group, prophylactic and therapeutic groups. The control group was infused with 20 µl PBS, E.coli group was administered with 10 [6] cfu/20 µl E. coli, and probiotic group was administered with Lactobacillus (10 [8] cfu/20 µl) for 10 consecutive days. In prophylactic group, the vagina was colonized with 10 consecutive doses of Lactobacillus (10 [8] cfu/20 µl). After 24 h, it was followed by 10 day intravaginal infection with E. coli (10 [6] cfu/20 µl) whereas for the therapeutic group vagina was colonized with (10 [6] cfu/20 µl) E. coli for 10 consecutive days, followed by 10 day intravaginal administration with Lactobacillus after 24 h. Upon mating and completion of gestation period, control, probiotic and the therapeutic groups had litters in contrast to the prophylactic group and the group administered with E. coli. Results indicated that Lactobacillus intermitted colonization of pathogenic strains that resulted in reinforcement of natural microflora and resurge fertility.

In this trial, which was stratified by time since menopause (<6 or ≥10 years), 17β-estradiol treatment was associated with less progression of atherosclerosis than was placebo when therapy was initiated early after menopause but not when initiated late after menopause. After dozens of observational studies consistently showed inverse associations between postmenopausal hormone therapy and the risk of coronary heart disease and death from any cause, it was difficult to understand the null or adverse effects of the therapy on coronary heart disease that were reported from randomized, controlled trials. One explanation is that in observational studies, women were younger (approximately 50 years of age) and closer to menopause (typically within 2 years) when they initiated hormone therapy than were the women included in randomized trials (mean age in the 60s, typically >10 years past menopause). This so-called timing hypothesis posits . . .

In this multicenter, randomized, placebo-controlled trial involving women with bacterial vaginosis who had completed a course of vaginal metronidazole gel, treatment with vaginally administered Lactobacillus crispatus CTV-05 (Lactin-V) resulted in a lower incidence of recurrence of bacterial vaginosis at 12 weeks than placebo.

Preventing HIV-1 infection is a high global priority. This study assessed prevention strategies in young women in South Africa, Uganda, and Zimbabwe using oral or vaginal antiretroviral agents. No approach was found to be effective. The HIV-1 incidence was 5.7 per 100 person-years. Daily oral preexposure prophylaxis with 300 mg of tenofovir disoproxil fumarate (TDF), alone or in combination with 200 mg of emtricitabine (FTC) (TDF-FTC [Truvada, Gilead Sciences]), reduces the risk of acquisition of human immunodeficiency virus type 1 (HIV-1) by 50% or more among persons with high adherence to the regimen, with demonstrated efficacy in men who have sex with men, heterosexuals, and injection-drug users. 1 – 4 On the basis of these observations, in July 2012 the Food and Drug Administration approved daily treatment with Truvada for the prevention of HIV-1 acquisition, and the Centers for Disease Control and Prevention has issued . . .

Progesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child. We did a double-blind, randomised, placebo-controlled trial of vaginal progesterone, 200 mg daily taken from 22–24 to 34 weeks of gestation, on pregnancy and infant outcomes in women at risk of preterm birth (because of previous spontaneous birth at ≤34 weeks and 0 days of gestation, or a cervical length ≤25 mm, or because of a positive fetal fibronectin test combined with other clinical risk factors for preterm birth [any one of a history in a previous pregnancy of preterm birth, second trimester loss, preterm premature fetal membrane rupture, or a history of a cervical procedure to treat abnormal smears]). The objective of the study was to determine whether vaginal progesterone prophylaxis given to reduce the risk of preterm birth affects neonatal and childhood outcomes. We defined three primary outcomes: fetal death or birth before 34 weeks and 0 days gestation (obstetric), a composite of death, brain injury, or bronchopulmonary dysplasia (neonatal), and a standardised cognitive score at 2 years of age (childhood), imputing values for deaths. Randomisation was done through a web portal, with participants, investigators, and others involved in giving the intervention, assessing outcomes, or analysing data masked to treatment allocation until the end of the study. Analysis was by intention to treat. This trial is registered at ISRCTN.com, number ISRCTN14568373. Between Feb 2, 2009, and April 12, 2013, we randomly assigned 1228 women to the placebo group (n=610) and the progesterone group (n=618). In the placebo group, data from 597, 587, and 439 women or babies were available for analysis of obstetric, neonatal, and childhood outcomes, respectively; in the progesterone group the corresponding numbers were 600, 589, and 430. After correction for multiple outcomes, progesterone had no significant effect on the primary obstetric outcome (odds ratio adjusted for multiple comparisons [OR] 0·86, 95% CI 0·61–1·22) or neonatal outcome (OR 0·72, 0·44–1·17), nor on the childhood outcome (cognitive score, progesterone group vs placebo group, 97·3 [SD 17·9] vs 97·7 [17·5]; difference in means –0·48, 95% CI –2·77 to 1·81). Maternal or child serious adverse events were reported in 70 (11%) of 610 patients in the placebo group and 59 (10%) of 616 patients in the progesterone group (p=0·27). Vaginal progesterone was not associated with reduced risk of preterm birth or composite neonatal adverse outcomes, and had no long-term benefit or harm on outcomes in children at 2 years of age. Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. The EME Programme is funded by the MRC and NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Research in Wales.

Preterm birth is a global health priority. Using a progestogen during high-risk pregnancy could reduce preterm birth and adverse neonatal outcomes. We did a systematic review of randomised trials comparing vaginal progesterone, intramuscular 17-hydroxyprogesterone caproate (17-OHPC), or oral progesterone with control, or with each other, in asymptomatic women at risk of preterm birth. We identified published and unpublished trials that completed primary data collection before July 30, 2016, (12 months before data collection began), by searching MEDLINE, Embase, CINAHL, the Maternity and Infant Care Database, and relevant trial registers between inception and July 30, 2019. Trials of progestogen to prevent early miscarriage or immediately-threatened preterm birth were excluded. Individual participant data were requested from investigators of eligible trials. Outcomes included preterm birth, early preterm birth, and mid-trimester birth. Adverse neonatal sequelae associated with early births were assessed using a composite of serious neonatal complications, and individually. Adverse maternal outcomes were investigated as a composite and individually. Individual participant data were checked and risk of bias assessed independently by two researchers. Primary meta-analyses used one-stage generalised linear mixed models that incorporated random effects to allow for heterogeneity across trials. This meta-analysis is registered with PROSPERO, CRD42017068299. Initial searches identified 47 eligible trials. Individual participant data were available for 30 of these trials. An additional trial was later included in a targeted update. Data were therefore available from a total of 31 trials (11 644 women and 16185 offspring). Trials in singleton pregnancies included mostly women with previous spontaneous preterm birth or short cervix. Preterm birth before 34 weeks was reduced in such women who received vaginal progesterone (nine trials, 3769 women; relative risk [RR] 0·78, 95% CI 0·68–0·90), 17-OHPC (five trials, 3053 women; 0·83, 0·68–1·01), and oral progesterone (two trials, 183 women; 0·60, 0·41–0·90). Results for other birth and neonatal outcomes were consistently favourable, but less certain. A possible increase in maternal complications was suggested, but this was uncertain. We identified no consistent evidence of treatment interaction with any participant characteristics examined, although analyses within subpopulations questioned efficacy in women who did not have a short cervix. Trials in multifetal pregnancies mostly included women without additional risk factors. For twins, vaginal progesterone did not reduce preterm birth before 34 weeks (eight trials, 2046 women: RR 1·01, 95% CI 0·84–1·20) nor did 17-OHPC for twins or triplets (eight trials, 2253 women: 1·04, 0·92–1·18). Preterm premature rupture of membranes was increased with 17-OHPC exposure in multifetal gestations (rupture <34 weeks RR 1·59, 95% CI 1·15–2·22), but we found no consistent evidence of benefit or harm for other outcomes with either vaginal progesterone or 17-OHPC. Vaginal progesterone and 17-OHPC both reduced birth before 34 weeks' gestation in high-risk singleton pregnancies. Given increased underlying risk, absolute risk reduction is greater for women with a short cervix, hence treatment might be most useful for these women. Evidence for oral progesterone is insufficient to support its use. Shared decision making with woman with high-risk singleton pregnancies should discuss an individual's risk, potential benefits, harms and practicalities of intervention. Treatment of unselected multifetal pregnancies with a progestogen is not supported by the evidence. Patient-Centered Outcomes Research Institute.

In this multicenter, randomized, double-blind, placebo-controlled trial involving women with vaginal bleeding in early pregnancy, treatment with progesterone during the first trimester did not result in a significantly higher incidence of live births than placebo.