Presently marketed vaginal barrier agents are cytotoxic and damage the vaginal epithelium and natural vaginal flora with frequent use. Novel noncytotoxic agents are needed to protect women from sexually transmitted diseases. One candidate compound is a high-molecular-mass form of soluble poly(sodium 4-styrene sulfonate) (T-PSS). The antimicrobial activity of T-PSS was evaluated in primary cultu...

OBJECTIVE Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration-approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%. MATERIALS AND METHODS This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging ...

BACKGROUND To assess the effect of a 12-day treatment using a vaginal gel based on niosomes containing hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera on vaginal microbiota, cervical epithelization and vaginal health. METHODS Open-label, prospective pilot study conducted in asymptomatic women in daily practice. Cer...

BACKGROUND Acidform gel, an acid-buffering product that inactivates spermatozoa, may be an effective topical non-hormonal contraceptive. This study was designed to evaluate the safety of vaginal dosing and effects of Acidform on mucosal immune mediators, antimicrobial properties of genital secretions, and vaginal microbiota. METHODS Thirty-six sexually abstinent U.S. women were randomized to ...

The vaginal mucosa is a common site for local and systemic delivery of medication. This study aims to compare the safety and toxicological profile of RheoSpray, a proprietary sprayable topical gel compounding base, to the profile of the positive control Gynoll II, using a 3D model of the human vaginal mucosa. Results have demonstrated that RheoSpray presented an ET50 superior to 24 hr, as oppos...

Background: HSV-2, one of the most common HIV-1 copathogens, establishes a synergistic interaction with HIV-1. Several clinical trials have shown that the anti herpetic drug acyclovir decreases HIV-1 viral load and delays HIV-1 disease progression. Similarly, CAPRISA004 reported that a vaginal gel containing 1% of the anti-HIV-1 drug tenofovir unexpectedly decreases the risk of HSV-2 acquisitio...

When developing novel microbicide products for the prevention of HIV infection, the preclinical safety program must evaluate not only the active pharmaceutical ingredient but also the product itself. To that end, we applied several relatively standard toxicology study methodologies to female sheep, incorporating an assessment of the pharmacokinetics, safety, tolerability, and local toxicity of ...

OBJECTIVE To compare oral misoprostol solution with vaginal prostaglandin gel (dinoprostone) for induction of labour at term to determine whether misoprostol is superior. DESIGN Randomised double blind placebo controlled trial. SETTING Maternity departments in three hospitals in Australia. Population Pregnant women with a singleton cephalic presentation at > or = 36+6 weeks' gestation, with...

Topical preexposure prophylaxis interrupts HIV transmission at the site of mucosal exposure. Intermittently dosed vaginal gels containing the HIV-1 reverse transcriptase inhibitor tenofovir protected pigtailed macaques depending on the timing of viral challenge relative to gel application. However, modest or no protection was observed in clinical trials. Intravaginal rings (IVRs) may improve ef...

Infection with human immunodeficiency virus (HIV) remains a global public health concern and is particularly serious in low- and middle-income countries. Widespread sexual violence and poverty, among other factors, increase the risk of infection in women, while currently available prevention methods are outside the control of most. This has driven the study of vaginal microbicides to prevent se...