Clinical Study With Investigational Cream Aims To Help Women Who Experience Painful Sex ~Participants needed in four locations for NeoGyn-sponsored clinical study
NEW YORK, Sept. 4, 2012 /PRNewswire/ -- NeoGyn Vulvar Soothing Cream is sponsoring a clinical study held in four medical centers throughout the United States to test the effectiveness of an investigational cream.
The study is being conducted at The Centers for Vulvovaginal Disorders in Washington DC, Pelvic & Sexual Health Institute in Philadelphia, PA, San Diego Sexual Medicine in San Diego, CA and Arizona Vulva Clinic. Additional applicants are needed for each location to participate in the randomized, double- blind, placebo controlled Research Study to evaluate a vulvar soothing cream containing cutaneous lysate for vulvar use.
Provoked vestibulodynia is classified as spontaneous pain in the vulvar region. The condition is typically characterized by pain at the entry point into the vagina during tampon insertion or sexual intercourse. Causes of provoked vestibulodynia can vary, which contributes to making it difficult for doctors to diagnose and treat this condition.
Each three month study will be led by physicians specialized in the field of women's health and vulvar care including, Dr. Andrew Goldstein, MD, Dr. Kristene Whitmore, MD and Dr. Susan Kellogg PhD, Dr. Irwin Goldstein, MD, and Dr. Joseph Brooks, MD. After inclusion, participants will attend one follow-up clinic visit, two telephone interviews and complete several questionnaires over the course of the study. The study cream and other study related tests, procedures and visits will be provided at no cost to each selected participant.
Eligible applicants are women who live in close proximity to the study sites and are 20-55 years old. Participants cannot be pregnant or breast-feeding and should be in a heterosexual relationship where a reliable form of birth control is being used. Pain experienced with the use of tampons or from intercourse are the top pre-requisites along with no medical history of heart disease, HIV, hepatitis B or C, or being post- menopausal.
NeoGyn's sponsorship of this clinical trial demonstrates the company's commitment to search for solutions in helping women with vulvar pain. The company's mission is also to help educate women and physicians on this not uncommon condition. NeoGyn encourages women to remain persistent in their quest for an accurate diagnosis and solution for vulvodynia
For more information about this clinical study or to see if you qualify, visit http://www.neogynstudy.org. For more information on vestibulodynia, visit http://www.neogyn.us, www.vaginalpainhelp.com, or www.nva.org.