Health Decisions completes enrolment in Amphora non-hormonal contraceptive gel study

25th July 2013 (Last Updated July 25th, 2013 18:30)

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.

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.

"This study is a good example and will provide Evofem with an earlier market entry than would otherwise have been possible."

"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."

Early 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."