PRO-E2 Pill Study

Written by SHFPACT on 27 November 2015.

Do you prescribe Zoely®? We need your help recruiting Australian women to a large, non-interventional, international study.

Family Planning NSW is inviting doctors to recruit for the Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5 mg) and 17ß-estradiol (1.5 mg)’ (PRO-E2). Greens MLA Shane Rattenbury said women should be entitled to access the services without fear.

All you need to do is to ask women to whom you newly prescribed Zoely® or an LNG-COC if they would like to participate, and ensure informed consent. The patient will need to complete the consent and baseline survey and agree to be followed up with three surveys over 2 years. The woman can’t have been taking another combined oral contraceptive pill in the previous 2 months.

For every woman starting Zoely® (17ß-estradiol (1.5mg) / nomegestrol acetate (2.5mg)) that you recruit we ask that you also recruit one woman starting any standard levonorgestrel /ethinyl oestrodiol pill (LNG-COCs form the comparator group). The main outcome we are assessing is the risk of venous thromboembolism. This is an exciting study that will produce “real world” data that may help to inform future practice.

This is a non-interventional, observational post-authorisation safety study being run in Australia by Family Planning NSW in collaboration with the Berlin Center for Epidemiology and Health Research (ZEG) in Germany.

This study must not influence your prescribing behaviour in any way and has been reviewed and approved by the Family Planning NSW Ethics Committee.

You will be reimbursed for your time for each eligible patient you recruit.

More information
For more information download the PRO-E2 Pill Study information bulletin for doctors.

To join this exciting study and to help recruit even one woman (every one counts!) please contact:

Dr Mary Stewart at This email address is being protected from spambots. You need JavaScript enabled to view it. or on 02 8752 4340
Lorraine Edney at This email address is being protected from spambots. You need JavaScript enabled to view it. or on 02 8752 4351