DURHAM, N.C., June 26, 2014 /PRNewswire-iReach/ -- Health Decisions, the full-service CRO of choice for forward-looking biopharma and medical device companies, today announced database lock for Evofem's phase 3 study of Amphora® nonhormonal contraceptive gel, the largest trial ever conducted of a nonhormonal contraceptive. Database lock marks an important milestone toward regulatory approval for Amphora, a potential alternative to Conceptrol®, the brand name of nonoxynol-9, the only spermicidal gel currently approved by the FDA.
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"We are pleased to announce early database lock for this 3,389-subject global study of a potentially important new contraceptive alternative for women worldwide," said Health Decisions CEO Michael Rosenberg, MD, MPH. "A combination of intensive study management based on streaming information and progressive subject-by-subject closeout enabled this important early step toward regulatory approval for a nonhormonal alternative to existing contraceptives."
"We are excited to have reached this important milestone in the development of Amphora," said Saundra Pelletier, CEO of Evofem Inc. "We really believe Amphora has tremendous potential to impact the lives of women, globally."
Importance of Amphora's Potential HIV-Preventative Effects If Confirmed
"We are excited about this Evofem development program both for now and future," Rosenberg stated. "In the near term, Amphora, if approved as a contraceptive, will provide women around the world with greater contraceptive choice. It will have an important place as an inexpensive, easy-to-use, woman-controlled product used only when necessary and on demand."
Looking at the longer term, Rosenberg said, "Although research will have to confirm this, Amphora may ultimately provide women for the first time with a single product that offers a combination of broadly effective contraception and HIV preventative effects." Rosenberg stated that this unique combination could have important implications for global world health, in part because, according to the World Health Organization and FDA-mandated labeling requirements in effect since December 2007, the currently marketed nonoxynol-9 vaginal gel may actually increase the risk of acquisition of HIV in some circumstances.
Largest Contraceptive Trial of Its Type Enrolled 3x-4x Faster
Rosenberg, recently honored by the Association of Clinical Research Professionals with its 2014 Award for Innovation in Clinical Research, stated that Health Decisions' innovative technology and processes enabled highly efficient study execution from startup through the most recent milestone, database lock.
"Our agile enrollment techniques enabled us to enroll almost 3,400 subjects three to four times faster than previous trials of similar products that enrolled less than half as many subjects. We enrolled 125 subjects per month compared with 38 subjects per month and 30 subjects per month for previous large studies of similar products. Our Agile Risk-Based Monitoring+ approach also enabled us to increase data quality simultaneously with reducing the percentage of data that was source verified."
About Health Decisions
Health Decisions is the CRO of choice for forward-looking biopharma and medical device companies and a driving force in the modernization of clinical development. Health Decisions uses data-driven insight and agility to deliver clinical development success, reduce timelines and risk and increase quality and returns for biopharma and medical device companies worldwide. For 25 years and in more than 300 clinical trials involving tens of thousands of patients in many therapeutic areas, Health Decisions has improved the efficiency of clinical development through innovative methodology, processes and technology. Health Decisions' clinical-development services have enabled biopharma and device companies to bring new products to market faster and at lower cost, thus providing the public with earlier access to improved treatments and diagnostics at more affordable prices. Health Decisions is headquartered in Durham, NC and operates on five continents.
Evofem LLC is a privately held biotechnology company that brings advanced prescription and consumer products to global markets. Through its subsidiaries, Evofem Inc. and Cosmederm Bioscience, Evofem discovers, develops and commercializes prescription and over-the-counter products, in the areas of dermatology, pain management, feminine care, contraception, and the prevention of sexually transmitted infections. In February 2013, Evofem entered into a strategic alliance with WomanCare Global, a nonprofit organization whose mission is to provide access to quality, affordable, women's healthcare products through a sustainable supply chain in over 100 countries, with a particular focus on under-served markets in Africa, Asia, and Latin America. Through this alliance, WomanCare Global provides sales, marketing and global distribution support to Evofem's products.
VP, Corporate Communications
Media Contact:Leslie Hammill, Health Decisions, 9199671111 ext. 520, firstname.lastname@example.org
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SOURCE Health Decisions