Changes In Vaginal Flora Research Articles

Injection Treatments for Vulvovaginal Atrophy of Menopause: A Systematic Review.

Injection treatments have been proposed as novel treatment options for Vulvovaginal Atrophy of Menopause (VVA) also known as Genitourinary Syndrome of Menopause (GSM). However, to date data about these treatments are poor. To assess all available injection treatments for VVA. A systematic review was performed by searching five electronic databases for peer-reviewed studies that assessed injection treatments for VVA. Eight studies (7 observational and 1 randomized) with 236 women were included. Assessed injection materials were: autologous platelet-rich plasma (PRP) + hyaluronic acid (HA), not cross-linked HA plus calcium hydroxyapatite (NCLHA + CaHA), micro-fragmented adipose tissue (MFAT), hyaluronan hybrid cooperative complexes (HCC), crosslinked HA, microfat and nanofat grafting + PRP, and PRP alone. Improvement in GSM symptoms after treatment was assessed through Visual Analogic Scale (VAS) for GSM symptoms or patient satisfaction, several validated questionnaires (FSFI, VHI, FSD, SF12, ICIQ UI SF, PGI-I, FSDS-R, VSQ), symptoms severity, changes in vaginal mucosa thickness, flora, pH, and expression on vaginal mucosal biopsies of Procollagen I and III and ki67 immunofluorescence or COL1A1 and COL3A1 mRNA. Injection treatments showing significant improvement in GSM-related symptoms were: (i) HCC in terms of VAS for GSM symptoms and FSFI score; (ii) Crosslinked HA in terms of VAS for GSM symptoms, FSFI and VHI score, COL1A1 and COL3A1 mRNA expression on vaginal mucosal biopsies; (iii) NCLHA + CaHA in terms of FSFI score; (iv) PRP + HA in terms of VHI, FSD and SF12 score; (v) microfat and nanofat grafting + PRP in terms of VHI score and FSDS-R score; (vi) PRP alone in terms of VHI and VSQ scores. All assessed injection treatments except for MFAT seem to lead to significant improvement in VVA symptoms on validated questionnaires. Further studies are necessary in the field. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

(002) The Effects of Vaginal Testosterone versus Placebo on Female Sexual Function: Interim Analysis of the PIVoT Trial (Prevention of Recurrent Urinary Tract Infection using Vaginal Testosterone)

Abstract Introduction Post-menopasual women experience changes in vaginal flora and vaginal atrophy that have been associated with declining estrogen levels. These changes to the vaginal microenvironment often lead to significant genital pain and discomfort during sexual intercourse. Vaginal estrogen treats atrophy thereby restoring flora, which prevents UTIs and improves sexual function in post-menopausal women. While estrogen is effective, some patients have contraindications or are unwilling to use it. Vaginal testosterone cream (VT) has been shown to improve vaginal atrophy, however, its effects on overall vaginal health and sexual function have not been fully described. Objective The purpose of this study was to determine if VT is more effective than placebo cream in restoring the vaginal flora, improving the vaginal health index (VHI), and the sexual function of postmenopausal women with recurrent UTIs. Methods This is an interim analysis of a randomized, double- blind placebo-controlled pilot study enrolling postmenopausal women with recurrent UTIs. Vaginal health index (VHI) and swab to assess flora via DNA sequencing were collected. Patients were randomized to VT or placebo. Female sexual function index (FSFI) questionnaires were administered at baseline, one month, and nine months post treatment. Results A total of 44 women have been enrolled. Average VHI at enrollment was 13.66 +/− 0.4. There was no difference in baseline characteristics among the groups. Results show an improvement in female sexual function index scores in both groups from baseline. In the VT arm, improvements were seen in the desire (2.18 to 2.85), lubrication (1.74 to 2.175), orgasm (1.64 to 2.5) and pain (0.91 to 1.3) domains of the FSFI. Interestingly, improvements in all domains were seen in the placebo group, however, more patients in this group reported being sexually active. In terms of VHI, there was a statistically significant increase in VHI scores at 9 months post-treatment with VT (14.65 +/−4.20 to 17.50 +/− 4.43, p = 0.04). This increase in vaginal health index was not observed in the placebo arm. Conclusions Initial data demonstrates improvement in vaginal pH and VHI after 9 months of treatment with VT. Improvement in sexual function scores were also seen in both the treatment and the placebo groups. Higher patient enrollment and longer treatment follow up will be valuable in understanding the effects of VT versus placebo on sexual function among postmenopausal women. Disclosure No

56. Association between vaginal microflora, high-risk hpv infection and hpv e6/e7 expression in high grade cervical intraepithelial neoplasia

Introduction: Role of persistent high-risk HPV infection is essential in development of cervical precancerous lesions. HPV achieves persistent expression by integration of E6 and E7 oncogenes into host genome. Vaginal flora changes can result in proinflammatory environment, that facilitates E6 and E7 expression. Aim of the study was to assess an association between HPV E6/E7 expression, vaginal microflora and high-risk HPV infection in women with high grade cervical intraepithelial neoplasia. Methods: Cross-sectional study was performed in July 2016-June 2017. 62 patients aged 18 to 50 referred for colposcopy to Riga East Clinical University Hospital and with histologically proven CIN 2 or worse were included in the study. Material from cervix was tested for HR HPV DNA types 16/18, 31, 33, 45, 58 and high-risk HPV E6/E7 RNA with real time PCR. Wet mount microscopy of vaginal material was performed using phase-contrast microscope and interpreted according to modified Donders-Schrӧder scale. Data analysis was performed with MS Excel 2019. Results: E6/E7 RNA expression was positive in 58/62 patients. 42/62 patients were HR-HPV positive and 41 of them had E6/E7 expression. From 20 HPV negative patients 17 were E6/E7 positive. 30/62 women had abnormal vaginal flora. In HPV positive group 18/42 had abnormal vaginal flora vs. 12/20 in HPV negative group. (p=ns). In E6/E7 RNA positive group 28/58 had vaginal flora changes vs. 2/4 in E6/E7 negative group. In HR HPV positive/ HPV E6/E7 positive group 18/41 had abnormal vaginal flora vs. 2/3 in HR HPV negative/ HPV E6/E7 negative group (p=ns). Conclusions: In the current study we were not able to find an association between vaginal flora changes, HPV E6/E7 expression and high-risk HPV infection. Larger studies are needed to further asses these associations.

Association between Vitamin D Deficiency and Bacterial Vaginosis among First Trimester Pregnant Women in Erbil Maternity Hospital

Background: Bacterial vaginosis (BV) is a polymicrobial clinical syndrome characterized by changes in vaginal flora, with replacement of normally abundant Lactobacillus species by high concentrations of anaerobic bacteria among reproductive age women. Studies have different aspects on the effect of vitamin D on BV. Objective: To find out the prevalence of BV, vitamin D deficiency in early pregnancy and to examine association between BV and vitamin D deficiency. Patients and Methods: A cross-sectional study was carried out during July 2017 till October 2018 among 100 pregnant women at first trimester pregnancy, aged 18-35 years old at Erbil Maternity Hospital. Results: At enrollment the prevalence of BV was (53%), about (73%) of our clients suffering from homogenous white greyish vaginal discharge, (57%) were with elevated vaginal PH and fishy odor, clue cells was found among (53%) of them. Vitamin D deficiency, defined as 25 (OH) D concentration below 20 ng/ml, was found in (67%) of women. Insufficiency of the vitamin D 25(OH) D concentration between 20-30ng/ml was present in (29%) of the women. Sufficient level of 25 (OH) over (30 ng/ml) was found in (4%). The incidence of Vitamin D pattern among women with BV were (49.3%), (62.1%) and (50%) respectively for each vitamin D deficiency, Insufficiency and sufficient vitamin D. No significant association was found between Vitamin D deficiency and BV. Conclusion: High occurrence of BV and vitamin D deficiency were found. Vitamin D was not associated significantly with increased BV incidence. We suggested that pregnant women should check and manage their level of vitamin D and BV additionally they must not depend only on vitamin D for curing BV.

Change in Vaginal Flora as Indicated by Pap Smear (Schröder’s Classification) in Women Using Levonorgestrel-Releasing Intrauterine System “Mirena”—Prospective Cohort Study

Background: The use of intrauterine device alters the normal balance between vaginal flora. It might change cervicovaginal environment, which was suggested to increase the risk for vulvovaginitis. It was found that up to 85% of levonorgestrel-releasing intrauterine system users become amenorrheic 4 months after insertion, or bleed only sporadically. It was hypothesized that this would have a beneficial effect on vaginal flora maintaining normal balance. Objectives: The aim of this study was to detect the effect of hormonal intrauterine system (“Mirena”: 20 microgram/24 hours intrauterine delivery system Levonorgestrel) on vaginal flora by using pap smear before and 6 months after insertion. Study design: A prospective cohort study was carried out in a university maternity hospital. 210 subjects were included with pap smear taken at time of insertion of IUS “Mirena” and another one taken 6 months later to detect percentage of incidence of infection in IUS users. Vaginal flora was studied, and lactobacilli were graded according to Schr?der’s classification. A comparison was made to allow detection of changes in vaginal flora caused by presence of hormonal IUS “Mirena”. Results: Over half of cases (57.2%) showed worse vaginal flora after hormonal IUS “Mirena” insertion than before. There was a highly statistically significant difference between Schr?der’s Grades before and after insertion (P value < 0.001) as 44.8% of cases presented by Grade I, 44.4% of cases presented by grade IIa, 38% of cases presented by grade IIb before insertion developed Grade III after insertion. Conclusion: Insertion of hormonal IUS “Mirena” results in significant change in microbial flora towards pathological bacteria.

Influence of a device intravaginal to synchronization/induction of estrus and its reuse in sheep vaginal flora

The objective of this study was to characterize the vaginal bacterial flora and their antibiotic susceptibility in vitro after, application, and the reuse of an intravaginal progesterone device (CIDR) in controlling the estrous cycle in sheep. Thirty Texel ewe lambs were used, after carefully assessed on their health and body condition. Experimental groups were formed by new CIDR (CIDRn, n = 15) and CIDR reused (CIDRu, n = 15). Treatment with progesterone lasted 6 days. Sterile swabs were used for vaginal sample collection, a procedure performed previously of CIDR insertion and on the moment of CIDR removing. The predominant flora prior to insertion of intravaginal devices proved to be 93.3% (14/15) and 80.0% (12/15) of gram-positive agents, especially of the genera Bacillus sp. and Staphylococcus sp. in CIDRn CIDRu groups, respectively. Upon removal of the devices, however, it was observed that the emergence of gram-negative agents in 100% of the samples CIDRn, most of them belonging to the Enterobacteriaceae genus. In CIDRu group, there was a balance between negative- and gram-positive agents on the removal of the devices. Regarding to susceptibility, our findings revelated some degree of resistance in all samples. Therefore, our conclusions pointed out that intravaginal devices (CIDR), when employed in the first use, or reuse, for a period of 6 days, promote a change in vaginal flora of sheep, highlighting the predominance of gram-negative agents during its removal.

Prevalence of vaginitis in different age groups among females in Greece

Patients with vaginitis were classified into four groups: Group A (prepubertal under-aged females); Group B (pubertal under-aged females); Group C (reproductive age adult females); Group D (postmenopausal adult females). All vaginal specimens underwent microscopy, amine testing, Gram staining and culturing. Overall, 163 patients were included (33, 14, 81 and 35 patients, respectively). The most common infection was bacterial vaginosis (BV), followed by Ureaplasma infection, aerobic vaginitis (AV) and candidiasis. The most common AV-associated organism was Escherichia coli and the most common BV-associated organism was Gardnerella vaginalis. AV was more frequent in Group A, BV in Group C and Ureaplasma infections in Groups C/D. Decreased lactobacilli concentrations were associated with BV in fertile patients (Groups B–C). Although presentation of vaginitis is similar among females of different age in Greece, type and prevalence of pathogens differ. Normal vaginal flora changes are associated with higher risk of vaginitis in specific age groups.Impact StatementThe worldwide incidence of reproductive tract infections has been increasing, with specific pathogens being associated with significant risk of morbidity and complications. However, literature data on the distribution of such infections in different age groups is limited.Therefore, the aim of this study was to provide data on the prevalence and causes of vaginitis in adult and non-adult females of all ages.This study has shown that although presentation of vaginitis is similar among females of different age groups and menstrual status in Greece, type and prevalence of responsible pathogens are different among groups. Changes in normal vaginal flora seem to be associated with higher risk of vaginitis in specific age-groups as well. These findings could contribute in adjusting diagnostic and therapeutic strategies for each age group according to the prevailing pathogens. Further research on antibiotic resistance and treatment outcomes for each age group should be conducted.

Bacterial Vaginosis Is Associated with Loss of Gamma Delta T Cells in the Female Reproductive Tract in Women in the Miami Women Interagency HIV Study (WIHS): A Cross Sectional Study.

Bacterial vaginosis (BV) is the most common female reproductive tract infection and is associated with an increased risk of acquiring and transmitting HIV by a mechanism that is not well understood. Gamma delta (GD) T cells are essential components of the adaptive and innate immune system, are present in the female reproductive tract, and play an important role in epithelial barrier protection. GD1 cells predominate in the mucosal tissue and are important in maintaining mucosal integrity. GD2 cells predominate in peripheral blood and play a role in humoral immunity and in the immune response to pathogens. HIV infection is associated with changes in GD T cells frequencies in the periphery and in the female reproductive tract. The objective of this study is to evaluate if changes in vaginal flora occurring with BV are associated with changes in endocervical GD T cell responses, which could account for increased susceptibility to HIV. Seventeen HIV-infected (HIV+) and 17 HIV-uninfected (HIV-) pre-menopausal women underwent collection of vaginal swabs and endocervical cytobrushes. Vaginal flora was assessed using the Nugent score. GD T cells were assessed in cytobrush samples by flow cytometry. Median Nugent score was 5.0 and 41% of women had abnormal vaginal flora. In HIV uninfected women there was a negative correlation between Nugent score and cervical GD1 T cells (b for interaction = - 0.176, p<0.01); cervical GD1 T cells were higher in women with normal vaginal flora than in those with abnormal flora (45.00% vs 9.95%, p = 0.005); and cervical GD2 T cells were higher in women with abnormal flora than in those with normal flora (1.70% vs 0.35%, p = 0.023). GD T cells in the genital tract are protective (GD1) and are targets for HIV entry (GD2). The decrease in cervical GD1 and increase in GD2 T cells among women with abnormal vaginal flora predisposes women with BV to HIV acquisition. We propose to use GD T cell as markers of female genital tract vulnerability to HIV.

Recurrent urinary tract infection in older women: an evidence-based approach

Ageing increases the risk of a woman developing a urinary tract infection (UTI). It also increases the risk of misdiagnosis and inappropriate antibiotic therapy being prescribed. Antibiotic therapy has costs as well as benefits and can lead to changes in gut and vaginal flora that further predispose older women to UTI. Antibiotic resistance is growing and those who do have a UTI may experience treatment failure because of resistance to commonly used antibiotics. Accurate diagnosis and effective evidence-based treatment becomes even more crucial in the face of an ageing population and increasing antimicrobial resistance. Furthermore, the need for specific evidence-based guidelines for UTI in older people is increasing.

A pilot study of the feasibility of a vaginal washing cessation intervention among Kenyan female sex workers

BackgroundIntravaginal practices including vaginal washing have been associated with HIV-1 acquisition. This association may be mediated by mucosal disruption, changes in vaginal flora or genital tract inflammatory responses. Reducing vaginal...

BACTERIAL VAGINOSIS IN INDIAN WOMEN IN THE REPRODUCTIVE AGE GROUP

Background : Bacterial vaginosis is a vaginal infection in women in the reproductive age group with complex change in vaginal flora. Many women are asymptomatic but some women present with abnormal vaginal discharge. It can lead to complications like preterm birth, infertility, post partum endometritis and first trimester loss. Nugent criteria are used to diagnose bacterial vaginosis. Objectives : This study was done with the objective of analyzing the type of bacteria causing vaginosis in different age groups during the reproductive period of a woman life. 100 women with vaginal discharge (test group) and 50 women (control group) attending the gynaecology outpatient for other problems were included in the study. Three high vaginal swabs were taken and examined for clue cells and mobiluncus spp. pH of the vaginal secretions was noted. Gram stain was done to quantify bacterial morphotypes. Diagnosis was done using the Nugent scoring system. Results : A significantly high incidence (p 0.05) was found in the test group. 53% of women with vaginal discharge were in the age group of 21-30 years indicating that vaginosis is very common in the early reproductive years. Mobiluncus spp. was found only in the test group. 46% had an abnormal Nugent score and

The Natural History of Bacterial Vaginosis Diagnosed by Gram Stain Among Women in Rakai, Uganda

Large datasets for investigating vaginal flora change at frequent, repeated intervals are limited and graphical methods for exploring such data are inadequate. We report 2-year weekly vaginal flora changes based on Gram stain using lasagna plots. Weekly vaginal flora patterns were evaluated among 211 sexually experienced women with ≥18 months of follow-up in Rakai, Uganda. Vaginal flora swabs were self-collected weekly and categorized by Nugent Gram stain criteria (0-3, normal; 4-6, intermediate; 7-10, bacterial vaginosis [BV]). Vaginal flora patterns were analyzed as the percentage of weekly observations with BV (longitudinal prevalence) and illustrated by lasagna plots. Characteristics of women were compared across tertiles of longitudinal prevalence of BV. Ninety-five percent of women had at least 1 episode of BV over 2 years, with one-third of women spending more than half (52%-100%) of their time with BV. Vaginal pH >4.5 increased with increasing tertiles of longitudinal prevalence of BV (P < 0.001). Weekly fluctuation in vaginal flora states, as measured by a change in flora states from the before current visit, was highest in the middle (41.9%) compared with the lower (30.1%) and upper tertiles (27.8%, P < 0.001). HIV status and reported vaginal symptoms did not differ significantly across BV tertiles. Women exhibited different patterns of vaginal flora changes over time, which could not be described by baseline behaviors. Lasagna plots aided in describing the natural history of BV within and across women and may be applied to future BV natural history studies.

Characteristics of patients with subchorionic hematomas in the second trimester

The aim of this study was to investigate the etiological characteristics of patients diagnosed with subchorionic hematoma. A case-controlled study was performed to compare characteristics of patients and controls. Via ultrasound examination, 47 pregnant patients were found to have subchorionic hematomas and 1075 had no evidence of subchorionic hematomas (controls). In the second trimester, patients were compared with regard to endocervical Chlamydia trachomatis and other vaginal microorganisms. The overall incidence of subchorionic hematomas in this pregnant population was 4.2%. Maternal clinical characteristics did not differ between cases and controls. Evaluation of the vaginal flora revealed that the positive rates of coagulase-negative staphylococci (cases: 12.8%; controls: 4.1%; P<0.01) and Gardnerella vaginalis (cases: 12.8%; controls: 2.5%; P<0.001) in the cases were significantly higher than those of the controls. The negative rate of Lactobacillus in the cases was significantly higher than that of the controls (cases: 42.6%; controls: 27.6%; P<0.05). Pregnant women with subchorionic hematoma in the first trimester showed changes in vaginal flora in the second trimester, which suggests a possible association with subchorionic hematoma and vaginal flora change.

Bacterial Vaginosis and Risk for Trichomonas vaginalis Infection: A Longitudinal Analysis

Bacterial vaginosis (BV) and Trichomonas vaginalis (TV) have been estimated to affect one-quarter to one-third of sexually active women worldwide, and are often found concurrently. Few studies have examined this relationship longitudinally to better understand the direction and temporality of this association. Between 2005 and 2006, a cohort of 853 young, sexually active women was followed in Mysore, India; participants were interviewed and tested for BV and TV at baseline, and at 3- and 6-month visit. Generalized estimating equations were used to estimate how changes in vaginal flora between consecutive visits-as defined by Nugent diagnostic criteria for BV-were related to the risk of TV infection at the latter visit, adjusted for sociodemographic and behavioral covariates. Treatment was offered to women with TV and/or symptomatic BV. After adjustment for covariates, participants with abnormal vaginal flora at 2 consecutive visits had 9 times higher risk of TV (95% CI: 4.1, 20.0) at the latter visit, relative to those with persistently normal flora. An increased risk of TV was also observed for participants whose flora status changed from normal to abnormal (adjusted risk ratio: 7.11, 95% CI: 2.8, 18.2) and from abnormal to normal (adjusted risk ratio: 4.50, 95% CI: 1.7, 11.8). Women experiencing abnormal flora during a 3-month span appear to have significantly increased risk of acquiring TV infection. Women of reproductive age in low-resource settings found to have abnormal vaginal flora should be assessed for TV.

P2-S2.13 A pilot study of the effectiveness of a vaginal washing cessation intervention among Kenyan female sex workers

BackgroundIntravaginal practices have been associated with HIV-1 acquisition. This may be mediated by mucosal disruption, changes in vaginal flora, or inflammatory responses in the genital tract. Reducing vaginal washing could...

Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004)

The study was designed to assess the safety, adherence, acceptability, and effect on vaginal microflora of 3% SPL7013 Gel (VivaGel), a novel dendrimer topical microbicide that inhibits HIV, herpes simplex virus-2, and human papillomavirus in vitro and in animal models. Phase 1, randomized, double-blind, placebo-controlled study on sexually active women. Sixty-one sexually active women aged 18-24 years were recruited from three sites in the United States. Participants were randomized 1: 1: 1 to receive VivaGel, VivaGel placebo, or a hydroxyethylcellulose (HEC) placebo twice daily for 14 consecutive days. Safety endpoints included genitourinary and/or other adverse events. Changes in vaginal flora were determined from Gram-stained vaginal smears and quantitative vaginal culture. No serious adverse events or withdrawals due to adverse events were reported. Genitourinary symptoms were reported as follows: VivaGel (n = 17/22; 77.3%), VivaGel placebo (n = 14/21; 66.7%), and HEC (n = eight of 18; 44.4%; not significant, P = 0.1). The incidence of abnormal pelvic examination findings was similar across all gel arms of the study. Using pairwise comparison, women in the VivaGel arm had a significantly higher incidence of related genitourinary adverse events compared with women in the HEC gel arm (0.297 versus 0.111 per 100 person-years, respectively; P = 0.003). Exposure to VivaGel and VivaGel placebo resulted in minor shifts in the vaginal microflora, but there was no overall impact on incidence of bacterial vaginosis as assessed by Nugent score. VivaGel was generally well tolerated and comparable with the VivaGel placebo, although there was a higher incidence of low-grade related genital adverse events compared to the HEC placebo gel.

Vaginal flora changes on Pap smears after insertion of levonorgestrel-releasing intrauterine device

Background The levonorgestrel intrauterine system (LNG-IUS) combines a uterine foreign body and the continuous release of low-dose levonorgestrel for contraception. Its influence on the rate of vulvovaginal infections and flora disturbance is insufficiently known, but important for contraceptive advice in women, especially those who develop recurrent vaginosis or Candida vulvovaginitis. Study Design Slides of 286 women who had a Pap smear taken before and 1 to 2 years after placement of a LNG-IUS were blindly reviewed for the presence of abnormal vaginal flora (AVF), bacterial vaginosis (BV), aerobic vaginitis (AV) and Candida vaginitis (CV). Results Prior to insertion, there were no differences in vaginal flora abnormalities between women using different kinds of contraception. LNG-IUS users did not have different rates of AVF, BV, AV or CV, but the general risk to develop any infection was increased. Uterine bleeding after insertion did not seem to predict a different flora type. Conclusion We found that Pap smears suggested more vaginal infections after 1 year of LNG-IUS use than prior to insertion of the device.

O230 Vaginal flora changes on Pap smears after insertion of intrauterine levonorgestrel releasing device (Mirena®)

International Journal of Gynecology & ObstetricsVolume 107, Issue S2 p. S158-S158 Free communication (oral) presentations O230 Vaginal flora changes on Pap smears after insertion of intrauterine levonorgestrel releasing device (Mirena®) G. Donders, G. DondersSearch for more papers by this authorJ. Berger, J. BergerSearch for more papers by this authorH. Heuninckx, H. HeuninckxSearch for more papers by this authorG. Bellen, G. BellenSearch for more papers by this authorA. Cornelis, A. CornelisSearch for more papers by this author G. Donders, G. DondersSearch for more papers by this authorJ. Berger, J. BergerSearch for more papers by this authorH. Heuninckx, H. HeuninckxSearch for more papers by this authorG. Bellen, G. BellenSearch for more papers by this authorA. Cornelis, A. CornelisSearch for more papers by this author First published: 20 November 2009 https://doi.org/10.1016/S0020-7292(09)60602-0AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume107, IssueS2Abstracts of XIX FIGO World Congress of Gynecology and ObstetricsOctober 2009Pages S158-S158 RelatedInformation

Microbicide safety and effectiveness: an overview of recent clinical trials

This review summarizes findings from recent vaginal microbicide safety and effectiveness trials and discusses the challenges associated with undertaking these trials. In safety trials, there has been a focus on the development of biomarkers of genital irritation. Recent safety studies have expanded the range of genital toxicity measures to include biomarkers of mucosal immunity, detection of haemoglobin in cervicovaginal lavage specimens and microbicide-induced vaginal flora changes. Four effectiveness trials have been stopped prematurely, two due to a lower than estimated HIV incidence rate, one as a result of an interim analysis suggesting increased risk of HIV acquisition among participants receiving active product, and one as a safety precaution. One effectiveness trial was completed and showed no reduction in HIV acquisition among participants receiving active product, and one ongoing effectiveness trial was modified by discontinuing a trial arm. Methodological challenges faced by these trials have included accurately estimating HIV incidence and pregnancy rates in trial populations, and improving adherence to and measurement of study product use. Validated safety and surrogate efficacy endpoints and standard ways of reporting them are being pursued. Focus has shifted to antiretrovirals containing microbicides, some of which may be used independent of coitus. Research on how to improve and measure adherence should continue.

A Randomized, Placebo-Controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel by Heterosexual Couples in Thailand

To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men. We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand. Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview. Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable. Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men.