Vaginitis and risk of sexually transmitted infections: results of a multi-center U.S. clinical study using STI nucleic acid amplification testing.

Unlabelled: Significant increases in rates of sexually transmitted infections (STIs) caused by (TV), (CT), (NG), and (MG) are occurring in the United States. We present results of a U.S.

Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306.

Ibrexafungerp is a novel antifungal treatment for acute vulvovaginal candidiasis (VVC). Using pooled data from two phase three studies (VANISH 303 and 306) in the treatment of acute VVC, this analysis sought to determine the effectiveness of ibrexafungerp in various patient subgroups that may impact outcomes. Data from VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620) evaluating ibrexafungerp 300 mg twice daily (BID) for 1 day versus placebo, were pooled and analyzed to determine clinical cure rate, clinical improvement, and mycological cure at the test-of-cure visit (day 11 ± 3) and symptom resolution at the follow-up visit (day 25 ± 4) in the overall population.

Oteseconazole: an advance in treatment of recurrent vulvovaginal candidiasis.

Recurrent vulvovaginal candidiasis (RVVC) has significant disease, financial and quality-of-life burdens, affects women from all strata of society worldwide, and lacks an approved therapeutic solution. Fluconazole emerged in 2004 as an antifungal for RVVC; it provides symptom control and has been accepted worldwide as a first-line treatment. Its limitations include the development of resistance and a high rate of vulvovaginal candidiasis recurrence after therapy cessation.

Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).

Objective: To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.

Design: Global phase 3, randomised, placebo-controlled superiority study.

Setting: Study sites in the USA (n = 19) and Bulgaria (n = 18).

Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis.

Background: Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile.

Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).

Background: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.

Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study.

Background: Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis.

Methods: Women with trichomoniasis, confirmed by a positive T.

Physician Awareness and Adherence to Clinical Practice Guidelines in the Diagnosis of Vaginitis Patients: A Retrospective Chart Review.

Vaginitis is one of the main causes of primary care and gynecological visits in the United States. The most common infectious causes are bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. A physician survey was conducted to measure awareness of vaginitis clinical guidelines and availability of in-office point-of-care (POC) diagnostic tools.

A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis.

Background: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC.

Sequence of Pelvic Examination Does Not Affect Patients With Baseline Vulvovaginal Syndromes: A Randomized Clinical Trial.

Objective: The purpose of this study is to determine the optimal sequence in performing a pelvic examination to reduce discomfort in patients with baseline vaginal pain.

Methods: A randomized controlled trial of women presenting for a new appointment at the Drexel Vaginitis Center was conducted. Women were assigned to either group A, a Q-tip touch test, speculum examination, then bimanual examination, or group B, a Q-tip touch test, bimanual examination, then speculum examination.

Fractionated CO2 Laser as Therapy in Recalcitrant Lichen Sclerosus.

Objectives: The aim of this study was to evaluate the efficacy of the fractionated CO2 laser in treating recalcitrant lichen sclerosus (LS).

Materials And Methods: The study population was 40 women diagnosed with LS who were symptomatic despite medical treatment. Patients had at least 2 or more laser sessions with a 2-month follow-up visit at the Drexel Vaginitis Center.

Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Vaginitis Assays: Results from a Prospective Multicenter Clinical Study.

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima vaginitis (CV/TV) assays.

Management of Resistant Trichomoniasis.

Purpose Of Review: Trichomonas vaginalis is the most prevalent sexually transmitted parasite in the USA; resistant infection is emerging. New drug therapies and dosing regimens of standard therapies are being studied to treat resistant infection.

Recent Findings: Diagnosis of trichomoniasis has become more sensitive, specific, and widely available with the advent of nucleic acid amplification tests (NAATs).

Current patient perspectives of vulvovaginal candidiasis: incidence, symptoms, management and post-treatment outcomes.

Background: Vulvovaginal candidiasis (VVC) is a common infection affecting women worldwide. Reports of patterns/risk factors/trends for episodic/recurrent VVC (RVVC) are largely outdated. The purpose of this study was to obtain current patient perspectives of several aspects of VVC/RVVC.

CD101 Topical Compared With Oral Fluconazole for Acute Vulvovaginal Candidiasis: A Randomized Controlled Trial.

Objectives: Vulvovaginal candidiasis (VVC) is an infection of the vagina's mucous membranes, caused by Candida albicans in more than 90% of acute VVC. Several topical and oral azole agents are available in a variety of formulations, and all seem to have similar effectiveness. Azoles are fungistatic, meaning that the fungi are inhibited from growth or replication but are not eradicated.

Metronidazole-Resistant Trichomoniasis: Beneficial Pharmacodynamic Relationship With High-Dose Oral Tinidazole and Vaginal Paromomycin Combination Therapy.

Metronidazole-resistant trichomoniasis is an uncommon condition that presents significant therapeutic challenges. Combination therapy with high-dose oral tinidazole and vaginal paromomycin cream has been uniformly successful. We present a case report of a patient who responded to combination therapy with high-dose oral tinidazole and intravaginal paromomycin.

Long-Term Outcomes of Women With Recurrent Vulvovaginal Candidiasis After a Course of Maintenance Antifungal Therapy.

Objectives: Data about long-term clinical outcome after a course of maintenance fluconazole in those with recurrent vulvovaginal candidiasis (RVVC) is lacking. We aimed to determine the rate of recurrence at a minimum of 6 months after completion of maintenance therapy.

Methods: A retrospective analysis of women with Candida albicans RVVC from January 2008 to January 2017 was performed using chart review to obtain information about recurrence after maintenance therapy.

A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial.

Background: Recurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC.

Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis.

Vaginitis is a common complaint, diagnosed either empirically or using Amsel's criteria and wet mount microscopy. This study sought to determine characteristics of an investigational test (a molecular test for vaginitis), compared to reference, for detection of bacterial vaginosis, spp., and Vaginal specimens from a cross-sectional study were obtained from 1,740 women (≥18 years old), with vaginitis symptoms, during routine clinic visits (across 10 sites in the United States).

A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of orally administered VT-1161 in the treatment of recurrent vulvovaginal candidiasis.

Background: Lanosterol demethylase is an enzyme that is essential for fungal growth and catalyzes an early step in the biosynthetic pathway of ergosterol, which is a sterol that is required for fungal cell membrane formation and integrity. Lanosterol demethylase is the molecular target of the class of drugs referred to as "azole antifungals." VT-1161 is a novel, oral, selective inhibitor of fungal lanosterol demethylase and is being developed for the treatment of recurrent vulvovaginal candidiasis.