The Vulvodynia Experience Questionnaire: Qualitative Development of a New Patient-Reported Outcome Measure for Vulvodynia.

Introduction: Vulvodynia is defined as vulvar pain of at least 3 months duration without a clear identifiable cause. There are currently no validated questionnaires that assess the experience of women with localized vulvodynia of the vestibule (vestibulodynia, previously known as vulvar vestibulitis) that meet the requirements of the Food and Drug Administration's Patient Reported Outcome (PRO) Guidance.

Aim: To develop a new content-valid PRO assessment in accordance with the Food and Drug Administration's PRO guidance to assess the symptoms and impacts of localized vulvodynia.

Pain assessment for chronic lower back pain: performance of the PAL-S and PAL-I patient-reported measures for symptoms and impacts.

The Patient Assessment for Low Back Pain-Symptoms (PAL-S) and the Patient Assessment for Low Back Pain-Impacts (PAL-I) were developed to incorporate patient perspective of treatment benefit in chronic low back pain (cLBP) trials. This study documents psychometric measurement properties of the PAL-S and PAL-I. In this multicenter, observational study, eligible participants clinically diagnosed with cLBP provided sociodemographic information and completed PAL measures and other patient-reported outcome measures of pain and/or disability.

Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial.

Chronic low back pain (LBP) is a common condition, usually with the involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first phase II, randomized, double-blind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate-to-severe chronic LBP with and without neuropathic pain component.

Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen.

Objective: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval.

Study Design: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.