title: A Feminine Care Clinical Research Program Transforms Women's Lives.
abstract: Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer's well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met.
authors.affiliation: . farage.m@pg.com.
authors.forename: Ghebre E
authors.initials: GE
authors.lastname: Tzeghai
authors.forename: Funmilayo O
authors.initials: FO
authors.lastname: Ajayi
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Miller
authors.forename: Frank
authors.initials: F
authors.lastname: Imbescheid
authors.forename: Jack D
authors.initials: JD
authors.lastname: Sobel
authors.forename: Miranda A
authors.initials: MA
authors.lastname: Farage
mesh_terms: D005260:Female; D053566:Hygiene Products / Q000706:statistics & numerical data*; D006266:Health Education / Q000379:methods / Q000706:statistics & numerical data; D006801:Humans; D052576:Menstrual Hygiene Products / Q000706:statistics & numerical data; D015397:Program Evaluation / Q000706:statistics & numerical data*; D011788:Quality of Life; D016387:Women's Health / Q000706:statistics & numerical data