Dose Of Gel Research Articles

Study of Influence of Vaginal Ph on the efficacy of Dinoprostone gel for Induction of Labor

Background: Inducing labor is a procedure intended to trigger artificial contractions of the uterus that generally involve progressive erasure and dilation of the cervix. This will hopefully lead to the birth of a baby through the vaginal route. To assess the efficacy of dinoprostone gel in cervical maturation and its effect on vaginal pH. Subjects and Methods: The participants were grouped by their vaginal pH into two groups. Group, I included patients with vaginal pH 4.5 and Group II included vaginal pH >4.5 and the differences between the groups with respect to maternal age, parity, gestational age. Those women with minimal change in Bishop Score, received up to 3 doses of dinoprostone gel intracervically, 6 hours apart. Women, who had no change in Bishop Score at the end of induction with 3 doses of dinoprostone, were further reassessed. Results: There was no statistically pertinent relationship between the two groups in regard to maternal age, gestational age, parity, and initial Bishop Score. The mean maternal age in Group I was 25.9 years and Group II was 26.9 years. The mean gestational age was 39.5 weeks in group I and 38.9 weeks in group II. The majority of subjects were primigravidas (70 percent in group I and 63 percent in group II). The mean Bishop score before labor induction was 3.6 0.9 in Group I and 4 1.0 in Group II. Out of 200 cases, 33 (23.3 percent) needed an improvement in Oxytocin, 33 (33.3 percent) in Group I and 4 (13.3 percent) in Group II. The vaginal delivery rate was 90% in Group I and 87% in Group II. The Caesarean section was marginally higher in Group II (10 percent) compared with Group I (13 percent). Conclusion: Parity has a major impact on the pre-induction of the Bishop Score and the pH itself has a vaginal influence. Knowing the pre-induction vaginal pH may also be a helpful method for determining the outcome of PGE2 induction.

Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial

PurposeThe effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.Methods216 women aged 25–60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed.ResultsRegression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present.ConclusionSAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.Trial registration numberISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040; retrospectively registered.

Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance

Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.

Comparison of ibuprofen and piroxicam gel in the treatment of trauma pain: A randomized double-blind trial of geriatric population

ObjectiveThis study aimed to compare the analgesic efficacy of topical ibuprofen and topical piroxicam for acute musculoskeletal injuries. MethodsIn this prospective, randomized, controlled, double-blinded study, geriatric patients were assigned to groups to receive either topical ibuprofen (n = 70) or topical piroxicam (n = 69). The first dose of gel was applied in the emergency department and the remaining doses were self-administered at home by the patients thrice daily for 72 h. For each patient, the initial baseline visual analog scale (VAS) score (V 0) was compared with the VAS scores at the 60 min (V1), 120 min (V2), 24 h (V3) and 72 h (V4) time points. The decreases in VAS scores, clinical effectiveness of the treatments, and incidence of adverse events were evaluated. ResultsIn the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001). The results were as follows: V0 –V: 1.08, 95% CI: 0.56–1.61; V0 –V2: 1.09, 95% CI: 0.49–1.69; V0 –V3: 1.44, 95% CI: 0.81–2.07; V0 –V4: 1.59, 95% CI: 0.91–2.26. The mean percentage decrease in the VAS scores in the topical ibuprofen group was significantly higher than that in the topical piroxicam group (p < .001). The clinical effect of treatment was found to be significantly higher for the ibuprofen gel group (p < .001). There was no substantial difference in treatment-related adverse events between the groups (p > .05). ConclusionIbuprofen gel, which is a safe treatment option for geriatric patients, is more clinically effective than piroxicam gel. Response to Reviewers:

Sonoelastography for the comparative assessment of cervical maturation after different approaches to cervical preparation ahead of labor induction

Aim To compare the efficacy of different approaches to cervical preparation to labor induction using the ultrasound cervical elastography. Materials and methods This prospective open-label study included 200 pregnant women aged between 23 and 38 years eligible for labor pre-induction. Patients were divided into four groups (n = 50 per group). In Group I, four osmotic Dilapan-S cervical dilators combined with two doses of oral mifepristone (200 mg each) 24 h apart were used. The dilators were inserted for up to 12 h. In Group II, only the Dipalan-S dilators were used. In Group III, a Foley catheter was positioned intracervically for 12 h. In Group IV, we used two doses of intracervical prostaglandin E2 gel (0.5 mg each) 6 h apart. Cervical maturation was assessed using the Bishop scoring system and the ultrasound cervicometry with the color mapping and calculation of SR ratio. At baseline, all participants were also divided into three subgroups depending on the Bishop score before the pre-induction. Subgroup А (n = 66) included patients with the Bishop score between 0‒2 points, subgroup B (n = 69) between 3–4 points, and subgroup С (n = 65) between 4–6 points. Results Our study showed that the efficacy of Dilapan-S combined with mifepristone for cervical preparation to labor induction was higher than Dilapan-S, Foley catheter and intracervical prostaglandin E2 gel. In this group, the Bishop score after the pre-induction was the highest (11.4 (0.21) points versus 10.2 (0.2), 9.4 (0.3) и 9.67 (0.25) in Groups II, III and IV respectively (p < .05 for all). The lowest SR values were also observed among the patients receiving the combination of Dilapan-S and mifepristone: 1.23 (0.04) versus 1.63 (0.07), 1.7 (0.08) and 1.83 (0.1) in Groups II, III and IV respectively (p < .05 for all). The sonoelastographic SR values in subgroups B and C were statistically lower compared with subgroup A across all groups studied. Ultrasound elastography of the cervix allowed to perform a more objective assessment of cervical maturation compared with the Bishop scoring. Conclusion Dilapan-S combined with mifepristone had higher efficacy for cervical preparation to labor induction compared with other approaches investigated.

Efficacy and safety study of an eyelid gel after repeated nocturnal application in healthy contact lens users and non-users

PurposeTo evaluate skin biocompatibility of a nighttime hydrating eyelid gel and possible ocular surface effects in contact lens users (CLU) and non-contact lens users (NCLU). The formulation is registered as a medical device as Tridocosahexaenoine-AOX® (TDHA-AOX) (a concentrated DHA triglyceride), containing also hyaluronic acid (HA). MethodsA prospective, randomized, masked clinical trial was performed with 62 participants of both sexes, aged 20–70 years, split into: (1) CLU (n = 30) and (2) NCLU (n = 32). All participants were instructed to apply a single dose of the moisturizing gel (containing TDHA-AOX and HA) nightly to the upper and inner eyelids of their right eye (RE) only, and during 2 consecutive weeks. Personal interviews, questionnaires, ophthalmic examinations and reflex tear collection were performed. Ophthalmological parameters included ocular surface response and contact lens status. Levels of satisfaction/adverse events were also recorded. Biochemical parameters included basal and final determination of pro-inflammatory mediator molecules in tear samples by multiplex analyses. Statistics were done by the SPSS 24.0 program. ResultsThe CLU group had higher OS dysfunction than NCLU, but overall clinical parameters (corneal staining, and Schirmer/FBUT tests) and OSDI scores showed significant improvement in CLU individuals as compared to the NCLU participants, at the end of study. CLDEQ-8 scores pinpointed significant amelioration in initial risk of developing DEs by applying eyelid gel. Multiplex analyses demonstrated significantly lower VEGF expression levels (p < 0,05) in tears among the CLU compared to NCLU after nightly application of eyelid gel. ConclusionsEyelid gel appeared to safely and efficiently provide hydration and decongestion of the skin and amelioration of the ocular surface during sleep.

Processing and characterization of MAGIC-f gel with ultraviolet/visible light spectrophotometry

The use of dosimetric gel in radiotherapy for quality control and verification of the dose delivered to the patient has gained prominence, since it is still the only three-dimensional dosimetry method. Based on this concept, the present work had the objective of processing the MAGIC-f polymeric gel with addition of fluorescein and characterizing it with UV/Vis (ultraviolet/visible light) spectrophotometry. The characterization of the samples was done 2, 7 and 34 days after irradiation with 6 MV photons and wavelengths between 300 and 600 nm. The results showed that the higher the dose, the lower the absorbance intensity measured by the equipment due to the increased polymerization degree, a satisfactory and expected result. It could also be concluded that the higher the irradiation dose of the MAGIC-f gel, the lower the fluorescein absorbance intensity – even a few days after irradiation– due to the continuity of polymerization. The MAGIC-f dosimeter with fluorescein has shown to be very promising, but further tests will be necessary to evaluate other dosimetric properties, such as energetic and dose rate dependence.

Evaluation of cellular and humeral immune response of sheep vaccinated with inactivated Rift Valley Fever vaccine adjuvanted with Montanide Gel

Abstract: Rift Valley Fever (RVF) is an acute infectious zoonotic arthopod - born viral disease, affecting many species of animals and it causes great economic losses in animal wealth and transmited to human and has zoonotic implication. Vaccination of susceptible animals with RVF vaccines are the important factor for controlling the disease. This study was applied to improve the ordinary vaccine by using Montanide gel 01as adjuvant with comparing the results with the Aluminiumhydroxyde inactivated RVF vaccine, through evaluating the humeral and cellular immune response and duration of immunity in sheep vaccinanted with the prepared vaccines. the antibody titre in the group vaccinated with montanide gel inactivated RVF vaccine reached the protective level at the 7th day post vaccinatin and stay within the proteceive level till the end of the 11th month in the group vaccinated with one dose of montanide gel inactivated RVF vaccine and till the end of 12th month in sheep vaccinated with the same vaccine. These results revealed that the best vaccine is 20% montanide gel inactivated RVF vaccine when used as two doses which gave higher level of antibody all over the period of the test compared with that of other vaccinated groups. Also the results of cell mediated immune response showed that: (i) The cell proliferation expressed by optical density showed early significance in sheep vaccinated by montanide gel inactivated RVF vaccine and slight elevation in sheep vaccinated by aluminium hydroxide gel inactivated RVF vaccine.

Characterisation of the inflammatory response triggered by topical ingenol mebutate 0.05% gel in basal cell carcinoma.

Ingenol mebutate gel is approved for actinic keratosis field therapy, but little has been published as a treatment of basal cell carcinoma (BCC). Our objective is to characterise the histopathological changes and the infiltrating cell populations to better understand its mechanism of action. Sixteen patients with various BCC subtypes were prospectively evaluated and treated once daily for two consecutive days with ingenol mebutate gel 0.05% under occlusion. Patients were randomised to two arms: the first arm was biopsied between the third and the tenth day after treatment initiation ('early immune response'), and the second arm was biopsied at day 30 after treatment initiation ('late immune response'). The immunopathology was evaluated by immunohistochemistry: anti-CD3, anti-CD4, anti-CD8, anti-CD20, anti-CD56, anti-CD68, anti-Bcl-2, anti-CASP3, anti-FoxP3, anti-GrzB and anti-TIA-1. Ten BCCs were in complete remission after 2years of follow-up. The early immune response was characterised by a quick recruitment of T lymphocytes, macrophages and natural killer cells. At later time-points, T-regulatory cells and some pro-apoptotic markers were detected. Treatment-related adverse events were described. Ingenol mebutate gel produces a transient immuno-inflammatory response and an important necrosis reaction in BCCs. Larger studies will be required to determine the maximum effective tolerated dose of ingenol mebutate gel for BCC.

A single oral dose of beetroot-based gel does not improve muscle oxygenation parameters, but speeds up handgrip isometric strength recovery in recreational combat sports athletes.

Although the effect of beetroot supplementation on exercise performance has been widely demonstrated to improve the performance of cyclists, runners, and swimmers, its effect on combat sports remains inconclusive. The present study assessed the effect of beetroot-based gel (BG) supplementation on maximal voluntary contraction (MVC), exercise time until fatigue (ETF), muscle O2 saturation (SmO2), and blood volume (tHb) in response to handgrip isotonic exercise (HIE) in recreational combat sport athletes. In a randomized, crossover, double-blind study, 14 combat sports athletes performed three sets of HIE (at 40% MVC) until fatigue after BG or nitrate-depleted gel (PLA) supplementation, in which forearm SmO2 and tHb were continuously monitored using near-infrared spectroscopy. MVC was evaluated at baseline and 20 min after HIE. MVC values were analysed as the change from baseline values (ΔMVC). There was a significant increase accompanied by a large effect size in ΔMVC (p = 0.036, d = 0.94) after HIE in the BG condition compared to PLA. However, there were no changes in SmO2 parameters (p> 0.05), tHb (p> 0.05) or ETF (p = 0.161) throughout the three sets of HIE. Additionally, a trivial to small effect size was observed in near-infrared spectroscopy (NIRS) parameters and ETF (d = ≤ 0.2 to 0.5). Therefore, a single dose of beetroot gel supplementation may be considered as a good nutritional strategy to improve strength recovery in combat sports athletes.

Perbaikan Kualitas Air Menggunakan Gel Lidah Buaya (Aloe vera)

Abstract: Water Quality Improvement Using Aloe Vera Gel. Some people on the Trikora road, Sidomulyo Permai Ujung Complex, Banjarbaru City use swamp water with turbidity levels that do not meet the requirements, namely 42 NTU. Water sources that do not meet the requirements must be processed. Aloe vera as a natural coagulant contains mucilage which contains polygalluronic acid as a coagulant with the mechanism of adsorption and incorporation. This study aims to determine the effectiveness of dose and time variation of aloe vera gel contact as a natural coagulant in reducing turbidity of swamp water. This type of research is experimental, namely to determine the optimum dose and contact time of aloe gel as a natural coagulant. The design of this study uses Postest Only Design. Data analysis usingstatistical test Two Way Analysis of Variance with α = 0.05. Turbidity level analysis results decreased after treatment of variations in dose and contact time, the optimum dose of 1.2 grams in the contact time of 20 minutes was able to reduce turbidity of 41,63% with turbidity value of 10.73 NTU, pH 4.6 and temperature of 28.5oC. It can be suggested for further research there should be an addition of natural additives that are alkaline to increase the pH of the water.

Mechanical Vector Control of Periplaneta Americana with Baiting Gel Application Containing Borax and Sulfur Material

Periplaneta Americana has long been acknowledged as mechanical vector for infectious diseases. Baiting gel is considered as an advantegous mechanical vector control because it is relatively affordable and convenient for users. However, further studies to understand dose-response effects and effective ingredient composition still limited. Therefore, the aim of this research was to analyze the effect of the combination doses of baiting gel with active ingredients boric acid and sulfur materials on Periplaneta americana mortality. This research was true experimental with Randomized Controlled Trial (RCT) study design. The researchers intervened the formula of baiting gel with a combination of boric acid and sulfur at different doses. The treatment of baiting gel at various dose levels produced a significant difference in the mortality of Periplaneta americana imago. Partial eta squared values showed the model design formed and the dose of baiting gel that had been applied had an effect on the mortality of Periplaneta americana imago at 90.4%. The observed power results show that the percentage to reject the hypothesis H0 for all diversity is 100%. The most effective dose in killing Periplaneta Americana cockroaches is a combination of Boric Acid: 10 grams and Sulfur: 0.25 grams. The conclusion of this research was to it is recommended to determine the weight of baiting gel before and after the application in order to optimize the results.

A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH

Purpose of Investigation: To determine change in vaginal pH and duration of change with intravaginal administration of single doses of Amphora vaginal gel (AVG). Materials and Methods: This Phase 1, randomized, placebo-controlled, double-blind, multicenter study included 105 women assigned to AVG 5-gram, AVG 4-gram, AVG 3-gram, placebo gel, or no treatment. Results: AVG at any of the three studied doses significantly lowered vaginal pH compared to placebo or no treatment. The effect was most pronounced in subjects with baseline vaginal pH levels ≥ 5. Peak reduction in vaginal pH with AVG occurred at 12 hours post-administration, with the greatest reduction occurring with the AVG 5-g dose. Subjects in the AVG treatment groups continued to have mean reduction in vaginal pH at Day 7 compared with baseline. Conclusion: Reduction from baseline in vaginal pH with 5-g AVG was significantly greater than with placebo or no treatment and persisted to Day 7 post-treatment.

Effects of transdermal administration of testosterone gel on the urinary steroid profile in hypogonadal men: Implications in antidoping analysis

Testosterone is one of the most abused pseudo-endogenous anabolic steroids in sport doping. The current method adopted to detect the abuse of testosterone and other pseudo-endogenous steroids (endogenous steroids when administered exogenously) is first based on the longitudinal monitoring of several urinary biomarkers, which constitute the so called “steroidal module” of the Athlete Biological Passport (ABP): atypical samples undergo a confirmation analysis based on the measurement of the 13C/12C isotopic ratio of selected target compounds, to distinguish their endogenous or exogenous origin. At the same time, testosterone administration can be allowed in athletes diagnosed with hypogonadism, provided they are granted a therapeutic use exemption by the relevant medical authority.In this pilot study we have investigated whether the approach based on the preliminary determination of the urinary steroid profile, in the format considered in the steroidal module of the ABP, also integrated with the inclusion of the sulfo-conjugates and of additional target steroids, can retain its validity also in the case of hypogonadal athletes. We have studied the effects of a single low dose (40 mg) of testosterone gel (T-gel) on the urinary concentration of the markers of steroidal module of the ABP, as well as on some additional steroid markers. The study was based on the analysis of urinary samples from 19 non-hospitalized hypogonadal men, 10 of them with late-onset hypogonadism (LOH), collected before, after 4 h and after 24 h the transdermal self-administration of 40 mg of T-gel. None of the patient had any co-morbidities possibly affecting the urinary excretion of the steroidal markers. The steroidal markers were quantified by gas chromatography coupled to tandem mass spectrometry (GC-MS/MS) after the enzymatic hydrolysis of the respective glucuro-conjugates and the chemical hydrolysis of the respective sulfo-conjugates. Targeted GC-MS/MS analysis was carried out operating in electron impact (EI) ionization mode, with acquisition in multiple reaction monitoring (MRM) mode.Our preliminary results show that, as expected, the treatment with T-gel leads, in all hypogonadal men, to an increase of the urinary concentration of the glucuro-conjugate metabolites of testosterone and its main metabolites, with special relevance to those with 5α-reduction. Furthermore, samples collected from non-LOH hypogonadal men showed an increase also in the levels of epitestosterone glucuronide, testosterone sulfate and epitestosterone sulfate. Apart from their biochemical and pharmacological relevance, these outcomes could be leveraged to refine the analytical strategy currently followed in the antidoping field for the analysis of the urinary steroidal markers, with potential implications also in other forensic and/or clinical investigations.

Randomized Controlled Trial to Assess the Impact of High Concentration Intraurethral Lidocaine on Urodynamic Voiding Parameters

To assess whether intraurethral anesthesia decreased voiding efficiency (VE), reduced catheterization pain, and impacted urodynamic parameters in healthy adult females. In a randomized, double-blind, placebo-controlled trial, participants received two 5 mL doses of either intraurethral aqueous gel or 4% lidocaine gel. The primary outcome was VE during randomized condition uroflow, defined as voided volume/(voided volume + residual volume). The secondary outcomes were pain during catheterization and to confirm previously reported pressure-flow changes. A sample size of 10 per group was planned to detect a clinically significant decrease in VE with a power (1-β) of 0.99. From October to December 2018, 23 women were screened and 18 were randomized to receive placebo (n = 10) or lidocaine (n = 8). Baseline uroflow VE was similar between the placebo and lidocaine groups (88 ± 6.6% vs 91 ± 5.8%, P = .33). After study drug administration, the changes in VE (post-pre) were similar between placebo and lidocaine groups (-5.4 ± 14% vs 1.7 ± 6.4%, P = .21). Visual analog scores were similar following catheterizations (26.7 ± 12.8 mm vs 36.9 ± 26.8 mm, P = .34). The lidocaine group exhibited lower average flow rates per voided volume (0.04 ± 0.02 s-1 vs 0.02 ± 0.01 s-1, P = .04). Intraurethral administration of 4% lidocaine did not decrease VE compared to placebo and did not change pain scores following catheterization. In the lidocaine group, the average flow rate per voided volume was lower. The decrease in flow rate after local anesthesia to the urethra may indicate that urethral sensory feedback contributes to voiding in human micturition.

PRE-IRRIGATION WITH GEL HIDRORETENTOR IN EUCALYPTUS SEEDLING ESTABLISHMENT IN THE FIELD

Research has sought new technologies aimed at establishing more productive forests. Hidroretentor gel that has the function of increasing the availability of water to the plant, in the most critical stage of establishment of the cuttings in the field. The objective of this study was to evaluate increasing levels of water retention gel applied in pre-irrigation, moments before planting, observing the survival index, and the morphological variables for the hybrid Eucalyptus grandis x E. urophylla-03, in Chapadinha-MA. The experiment was a randomized block with seven treatments and three replicates. The treatments consisted of five increasing doses of 1.0; 2.0; 3.0; 4.0 and 5.0 g 5 L-1 gel solution per liters of pre-irrigation, a treatment without the use of the gel; and a conventional planting treatment. The use of pre-irrigation with hidroretentores polymers, known as hidroretentor gel at a concentration of 4 and 5g 5L-1, provides a greater height, stem diameter, increasing the growth of eucalyptus plants in post-planting. The depth of the root system did not improve when a higher dose of gel was used, obtaining lower values than those obtained by the treatment without the use of the hidroretentor gel.

SUN-237 Higher Doses of Testosterone Gel Required in Hypogonadal Men with Obesity to Achieve Therapeutic Replacement - Advice on Dose Titration

Introduction: Testosterone (T) gel is one of the most widely used treatment options for hypogonadal men. Our clinical practice has shown that a great percentage of men achieve therapeutic T levels 3 weeks after the commencement of T gel. This achievement depends on the initiation dose of T gel which may be contingent on body composition primarily waist circumference (WC) as a marker of visceral obesity. Objectives: To determine whether hypogonadal men with WC≥102cm were required to be commenced at initiation on higher doses of T gel. To determine the time required to achieve therapeutic T levels (Tostran 2% gel v Testogel 1%). To look for other parameters which may help assess the initiation dose e.g. body weight, BMI. Methods: A cross-sectional study involving 300 hypogonadal men. 112 men were commenced on Tostran and 188 men on Testogel. The following were assessed: baseline WC and total T (TT) correlation, the initiation T dose and the time when therapeutic levels are achieved, the average starting dose achieving therapeutic T levels in obese (WC≥102) and non-obese (WC<102cm) men, correlation between T gel dose achieving therapeutic T levels and the quartiles of WC, BMI and body weight. Results: Baseline characteristics: mean age 62.3y; mean TT 7.4 nmol/l; WC 113.9cm, BMI 33.45, mean weight 102.4kg, starting T gel dose 51.4mg. There was a negative correlation between WC and TT (p=0.039). The majority of men were commenced on either 50mg (56.4%) or 60mg (21.8%) of T gel. 88.9% of men achieved therapeutic T levels (24.8% by 3 weeks, 56.2% by 3 months, 73.1% by 6 months, 89.3% by 12 months, 97.9% by 24 months). There wasn’t significant difference between Tostran and Testogel. When comparing obese and non-obese men, the average starting dose achieving therapeutic T levels at 3 months (48mg and 58mg, respectively) was trending towards statistical significance (p=0.065). T gel dose achieving therapeutic T levels was positively correlated to WC quartiles 1&4 + 2&4, BMI quartiles 1&2 + 1&4 + 3&4, and body weight quartiles 1&4. Conclusions: Our study, like other studies has shown that men with higher waist circumference, which is a surrogate marker of obesity and metabolic syndrome, have lower total testosterone levels. Testosterone gel which is commonly used in the treatment of hypogonadism is an effective way of hormone replacement. However, only half the number of patients achieve therapeutic levels by 6 months and some patients take up to 12-24 months to achieve therapeutic levels of testosterone. Our study demonstrates that higher doses of testosterone is required to achieve therapeutic levels in men with greater waist circumference, weight and BMI. We hence suggest differential initiation dose and titration regime for patients with varying degrees of obesity and metabolic syndrome to decrease the time taken to achieve therapeutic concentration of testosterone.

Comparison of intracervical Foley catheter used alone or combined with a single dose of dinoprostone gel for cervical ripening: a randomised study

Prostaglandins and intracervical catheters are similarly effective for cervical ripening and for an induction of labour (IOL). Studies comparing the combined use with either method alone have administered repetitive doses of prostaglandins vaginally, which may increase the risk of tachysystole and chorioamnionitis. These disadvantages may be offset by co-administering a single dose of prostaglandin. Women (n = 110) planned for IOL, ≥37 weeks of gestation and with a Bishop Score of ≤6 were randomised into two groups: intracervical Foley catheter alone or combined with dinoprostone gel (0.5 mg) for 12 hours followed by oxytocin. The primary outcome was the IDI and the others were: change in Bishop Score, caesarean section (CS) requirement, any complications and neonatal outcome. The baseline Bishop was ≤4 in all and >80% were nulliparous. The post-ripening Bishop was significantly higher (6.67 vs. 5.98; p = .045) and the IDI was significantly lower in the combined group (16 hours and 16 minutes vs. 20 hours 44 minutes, p = .002). The CS rate was similar (29.1 vs. 25.5%; p = .669). No woman had hyperstimulation or chorioamnionitis and the neonatal outcomes were similar. Thus, co-administering one dose of an intracervical PGE2 gel with Foley was superior to Foley alone for cervical ripening and IOL.Impact statementWhat is already known on this subject? Prostaglandins and intracervical balloon catheters used individually are similarly effective for ripening an unfavourable cervix prior to the induction of labour (IOL). A few studies which have compared their found it to result in a shorter cervical ripening time and induction delivery interval (IDI) as compared to prostaglandins alone, though chorioamnionitis was a concern. When compared to balloon catheter used alone, combined use was either similarly or more effective. The studies comparing combined use with either method used alone have administered repetitive doses of prostaglandins vaginally, which may increase the risk of tachysystole, and possibly of chorioamnionitis. Co-administering a single dose of prostaglandin with a balloon catheter may offset these disadvantages.What do the results of this study add? A combined method for cervical ripening using a single dose of intracervical dinoprostone gel (PGE2, 0.5 mg) coadministered with an intracervical Foley catheter was superior to Foley catheter alone. The combined method improved the Bishop score after 12 hours and reduced the IDI significantly compared to the Foley catheter alone; while the caesarean rate and neonatal outcomes were similar. No woman had chorioamnionits or hyperstimulation.What are the implications of these findings for clinical practice and/or further research? The combined methods for cervical ripening should be compared to individual methods in more women, and the combinations may explore the use of other single use prostaglandins like the dinoprostone vaginal insert or misoprostol tablets.

Validation of the Gel &amp; Wax Boluses and Comparison of their Dosimetric Performance with Virtual Bolus

Background: In general, radiotherapy treatment planning is performed using the virtual bolus. It is necessary to investigate physical bolus in comparison to virtual one.Objectives: In the present study, first, radiological properties of superflab Gel bolus and Paraffin wax bolus was investigated in terms of their relative electron density. Then, dosimetric performance of both the bolus (i.e. Gel and Parafin wax) was compared with Virtual bolusMaterial and Methods: In This experimental study, the radiological property of Wax and Gel boluses was investigated using two methods. In one, the relative electron density of both the Gel and Wax boluses was calculated by measuring their linear attenuation coefficient where in another method relative electron density was calculated by recording their CT No directly from their CT scan. Later CT scan of solid water slab phantom (dimension 30x30x15 cm3), with physical boluses (i.e. Gel and Wax bolus) of appropriate thicknesses required to deliver a dose of 200 cGy at Dmax using 4 MV, 6 MV and 15 MV photon beams, was taken. These CT data sets were retrieved to TPS. A plan was done to deliver a dose of 200 cGy at Dmax using Single 4 MV, 6 MV and 15 MV photon beams. Dose at depths Dmax, 1 cm, 2 cm, 3 cm, 4 cm and 5 cm was recorded. Using this similar method, doses at depths viz Dmax, 1 cm, 2 cm, 3 cm, 4 cm and 5 cm was recorded for the Gel and Wax boluses. The differences in dose of gel and wax bolus from virtual bolus were recorded for comparison of their dosimetric performance.Results: The measured (calculated) relative electron density of wax and Gel bolus was found to be 0.958 (0.926) and 0.923 (0.907), respectively. Variation in dosimetric performance of Gel and Wax with reference to Virtual bolus was studied. However, on average, Gel bolus was more consistent with virtual bolus.Conclusion: To avoid any dose difference between, delivered (using physical bolus) and planned (using virtual bolus), the physical boluses should be investigated for their dosimetric performance in comparison to virtual bolus. The results obtained and methodology used in this study can be applied in routine radiotherapy practices

Effect of Hormonal Contraception on Pharmacokinetics of Vaginal Tenofovir in Healthy Women: Increased Tenofovir Diphosphate in Injectable Depot Medroxyprogesterone Acetate Users

Endogenous and exogenous contraceptive hormones may affect mucosal pharmacokinetics (PKs) of topical antiretrovirals such as tenofovir. We present PK data from healthy women using tenofovir vaginal gel, at baseline (follicular and luteal phases) and after oral contraceptive pill (OCP) or depot medroxyprogesterone acetate (DMPA) use. CONRAD A10-114 was a prospective, interventional, open-label, parallel study. We enrolled 74 women and 60 completed the study (32 and 28 who selected OCPs or DMPA, respectively). Participants used 2 doses of tenofovir gel separated by 2 hours, without intercourse, and were examined 3 or 11 hours after the last dose. We assessed pharmacokinetics in plasma, cervicovaginal (CV) aspirate, and vaginal tissue. In general, there were no significant differences in mucosal tenofovir and tenofovir diphosphate concentrations (P > 0.23) in the follicular and luteal phases, except for lower mean tenofovir tissue concentrations (P < 0.01) in the follicular phase. Tenofovir concentrations significantly decreased in CV aspirate (P < 0.01) after contraceptive use, but overall remained very high (>10 ng/mL). Mean tissue tenofovir diphosphate increased to 6229 fmol/mg after DMPA use compared with 3693 and 1460 fmol/mg in the follicular and luteal phases, respectively (P < 0.01). The molecular conversion of tenofovir into tenofovir diphosphate was more effective in DMPA users (molecular ratio of 2.02 versus 0.65 luteal phase, P < 0.01). Both menstrual cycle phase and exogenous hormones affect topical tenofovir mucosal and systemic PKs. However, high levels of tenofovir and tenofovir diphosphate were observed in the CV mucosa in the presence or absence of OCPs and DMPA, with tissue levels exceeding benchmarks of predicted mucosal anti-HIV efficacy (tenofovir >1.00 ng/mL in CV aspirate and tenofovir diphosphate >1000 fmol/mg).