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Vaginitis clinical trials

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NCT ID: NCT02641717 Completed - Candidiasis Clinical Trials

Validity of Patient-Collected Wet Mounts

Start date: November 2015
Phase: N/A
Study type: Interventional

Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic. Research Design/Plan: Prospective, non-randomized, non-blinded trial Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal discharge, odor and/or itching). Calculate concordance between clinician- and patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount, using the clinician-collected specimens as the "gold standard." Clinical Relevance: A "wet mount," or microscopic examination, is commonly used to diagnose trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little information about patient-collected wet mounts exists in the literature. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. The method is highly acceptable to women. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome.

NCT ID: NCT02515656 Completed - Vaginitis Clinical Trials

Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

PRISM
Start date: September 2015
Phase: Phase 3
Study type: Interventional

POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969. Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone. The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

NCT ID: NCT02444481 Completed - Vaginitis Clinical Trials

Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information. Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment. Objectifs of the study: Principal objectif: Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis Secondary objectif: Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs. Numbers of patients previewed: 100 patients for evaluation of the efficacy Criteria of evaluation Principal criteria: Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results Evaluation of tolerance Used Study Drug: Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days Study design: Visit 1: All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening). A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment. Visit 3: After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.

NCT ID: NCT02365389 Completed - Vaginitis Clinical Trials

Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis

MNZ
Start date: May 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A previous study showed that in situ MTZ vaginal gel twice daily is more effective than the conventional vaginal gel product in sustained cure of BV( 4 weeks after treatment) (80.0% in the in-situ gel group as compared with 47.4 in the conventional gel group.The current study aims to compare the efficacy of the use of once daily in situ MTZ vaginal gel (0.8%) versus twice-daily conventional MTZ vaginal gel in treatment of BV.

NCT ID: NCT02313545 Completed - Atrophic Vaginitis Clinical Trials

Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

In this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at baseline and after 2 and 6 weeks of treatment. The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).

NCT ID: NCT02195986 Completed - Atrophic Vaginitis Clinical Trials

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

NCT ID: NCT02150525 Completed - Clinical trials for Ductal Breast Carcinoma in Situ

Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.

NCT ID: NCT02014428 Completed - Atrophic Vaginitis Clinical Trials

Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

Start date: n/a
Phase: Phase 4
Study type: Interventional

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

NCT ID: NCT01993524 Completed - Bacterial Vaginosis Clinical Trials

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.

NCT ID: NCT01874158 Completed - Clinical trials for Trichomonas Vaginitis

DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Start date: November 2012
Phase: Phase 4
Study type: Observational

The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.