Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Berlin Center for Epidemiology and Health Research (ZEG) and Family Planning NSW
Lead Doctor: Dr Mary Stewart
Ethics Committee: This study has been reviewed and approved by the Family Planning NSW Ethics Committee
Family Planning NSW seeks a network of doctors to recruit for an important, non-interventional, international PRO-E2* study
The study is assessing the safety of Zoely® and other levonorgestrel-containing combined oral contraceptive pills. The main outcome is to determine the risk of venous thromboembolism.
Participating doctors are required to recruit women to whom they have newly prescribed Zoely® or a levonorgestrel-containing combined oral contraceptive pill in a 2 year observational study. The women recruited for this study cannot have been taking another combined oral contraceptive pill in the previous 2 months. Doctors will be reimbursed $70 for their time for each eligible patient they recruit.
*Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5 mg) and 17ß-estradiol (1.5 mg)’
Benefits of Participation
- You will be helping to advance important medical research on the safety of the contraceptive pill.
- You will receive a monthly newsletter containing study updates and up to date information on reproductive and sexual health.
- This study must not have any influence whatsoever on your prescribing or on the decisions made by individual patients.
- If you decide to recruit for this study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your records relating to this study and any other information received will be kept strictly confidential.
Your Role in the Study?
Doctors who participate would be responsible for the following:
- Recruiting women for a two-year observational study
- Women must be prescribed Zoely® or a levonorgestrel-containing combined oral contraceptive pill
- Women have not taken a combined oral contraceptive in the
past two months.
- Providing the women with informational material and facilitating the patient completing the consent form and baseline survey.
- That is the extent of your role – PRO-E2 study staff will follow up directly with the study participants themselves.