Bacterial Vaginosis — Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Citation(s)
Allsworth JE, Peipert JF Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol. 2007 Jan;109(1):114-20. doi: 10.1097/01.AOG.0000247627.84791.91.
Edwards D, Panay N Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition? Climacteric. 2016 Apr;19(2):151-61. doi: 10.3109/13697137.2015.1124259. Epub 2015 Dec 26.
Larsson PG Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.
Nasioudis D, Linhares IM, Ledger WJ, Witkin SS Bacterial vaginosis: a critical analysis of current knowledge. BJOG. 2017 Jan;124(1):61-69. doi: 10.1111/1471-0528.14209. Epub 2016 Jul 11.
Ruiz FO, Pascual L, Giordano W, Barberis L Bacteriocins and other bioactive substances of probiotic lactobacilli as biological weapons against Neisseria gonorrhoeae. Pathog Dis. 2015 Apr;73(3):ftv013. doi: 10.1093/femspd/ftv013. Epub 2015 Feb 11.
van de Wijgert JHHM, Jespers V The global health impact of vaginal dysbiosis. Res Microbiol. 2017 Nov-Dec;168(9-10):859-864. doi: 10.1016/j.resmic.2017.02.003. Epub 2017 Mar 1.
Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.