Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
Journal Title: Clinical and Experimental Obstetrics & Gynecology - Year 2019, Vol 46, Issue 4
Abstract
Summary Purpose of Investigation: In 2016, the US Food and Drug Administration updated the enrollment and clinical response criteria for clinical studies of bacterial vaginosis (BV). The purpose of this post hoc analysis was to determine the effects of these differences on the results of a previously published phase 3 clinical study of the use of a single oral dose of secnidazole 2 grams to treat BV. Results: The updated guidelines for enrollment include a more stringent baseline Nugent score cutoff, which reduced the number of subjects from the initial study by 16.8% (secnidazole group) and 7.0% (placebo group). The updated efficacy guidelines changed the clinical outcome responder rates to 64.0% (secnidazole) and 26.4% (placebo) on assessment days 7–14 (p < 0.001), and to 58.4% and 24.5%, respectively, on days 21–30 (p < 0.001). Conclusion: Although the guidelines did not significantly affect efficacy outcomes, future BV studies will need to screen more patients to compensate for the new, more stringent enrollment criteria.
Authors and Affiliations
P. Nyirjesy, M. Padula, J. L. Amprey
Keywords
Related Articles
- EP ID EP673404
- DOI 10.12891/ceog4892.2019
- Views 68
- Downloads 0
Factors associated with the quality of life in women with perimenopausal and postmenopausal status: a cross-sectional questionnaire survey from China
Background: Many factors may influence the quality of life (QOL) of women with perimenopausal and postmenopausal status; however, systematic research is lacking. The purpose of the current study was to determine factors...
Vault prolapse occurrence after total laparoscopic hysterectomy and total abdominal hysterectomy performed for benign indications, is there a difference? A systematic review of the literature
Aim: To systematically review published data on vault prolapse occurrence after total laparoscopic hysterectomy versus abdominal hysterectomy for benign uterine pathology. Materials and Methods: Medline and PubMed were s...
Adjusting progesterone (P) dosage to compensate for a non-homogeneous hyperechogenic (HH) echo pattern three days after embryo transfer
Purpose: To determine if in the modern era failing to attain a homogenous hyperechogenic (HH) pattern three days after embryo transfer is still associated with a lower pregnancy rates. The study evaluates the efficacy of...
Myoinositol supplementation on intracytoplasmic sperm injection outcome in Japanese infertile polycystic ovarian syndrome women with non-obese less-androgenic phenotype: a prospective controlled observational study
Purpose of Investigation: The objective of this prospective controlled observational study was to evaluate the effect of myoinositol supplementation on intracytoplasmic sperm injection (ICSI) outcome in Japanese infertil...
The effect of VEGF and Ang-1 on cryopreserved human ovarian grafts in severe combined immunodeficient mice
This study investigates the independent and combined effect of vascular epithelial growth factor (VEGF) and angiopoietin 1 (Ang- 1) on the follicle survival and vasculogenesis of cryopreserved human ovarian grafts in sev...