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
Location: Australia
Lead Doctor: Dr Mary Stewart
Ethics Committee: This study has been reviewed and approved by the Family Planning NSW Ethics Committee

Researcher interview:

Background

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.

Your Rights

• 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.