Clinical research organisation Health Decisions has completed enrolment for 3,400-subject Phase III registration study of Evofem’s 3 Amphora non-hormonal contraceptive gel.
The global trial is designed to compare Amphora against Conceptrol, which is the brand name of the FDA approved only spermicidal gel nonoxynol-9.
Enrolment rate in the study is 125 subjects per month against 38 subjects per month and 30 subjects per month for previous large studies of similar products.
Health Decisions CEO Dr Michael Rosenberg said the enrolment has been completed well ahead of schedule.
"Our ability to use technology to enroll studies faster and to better retain subjects enables us to generate information more quickly than industry norms," Rosenberg said.
"This study is a good example and will provide Evofem with an earlier market entry than would otherwise have been possible."
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataEarly enrolment in the study was possible due to Agile Clinical Development technology-leveraged approach to run clinical trials based on immediate, actionable information from the field, according to the company.
The integrated adaptive monitoring approach works in line with principles as adaptive enrolment, while offering benefits such as reducing monitoring costs and increasing data quality, claimed the company.
Evofem Board chairman Tommy Thompson said: "Evofem is committed to providing women around the world with greater contraceptive choice and we expect Amphora to fill a critical gap in the market as an inexpensive, easy-to-use product that is woman-controlled and used only when necessary, on-demand."