ellaOne® Pregnancy Registry

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What is a Pregnancy Registry?

A pregnancy registry is a voluntary prospective program designed to collect and evaluate medical information on pregnancies and outcomes reported, following exposure to a pharmaceutical product.

What is ellaOne^®?

ellaOne^® is a female emergency contraceptive to be taken within five days of unprotected sex or contraceptive failure (such as a tear in a condom during sex).

What is the aim of the ellaOne^® Pregnancy Registry?

Since there is little data regarding pregnancies exposed to ellaOne^®, the collection of further data is needed to continuously monitor the safety profile of ellaOne^® during its commercialization. In agreement with the European Medicines Agency, HRA Pharma has decided to establish this registry to collect information on any pregnancy exposed to ellaOne^®, e.g. unrecognized pregnancy before intake or treatment failure.

Why should you advise your patient to participate in this pregnancy registry?

By participating in this pregnancy registry, the medical information provided by your patients will contribute to the collection of valuable information. The data collected will be analyzed and may be used to update the pregnancy section of the Summary of Product Characteristics of ellaOne® as appropriate.

Before enrolment in the registry, you should first inform each patient of the objectives and content of the registry. You should also provide each patient with information about the collection and processing of her personal and medical data and ensure that she agrees for these data to be collected in this registry. Patients should be reassured that any information used would be handled in an anonymous manner in order to preserve confidentiality.

We recommend that you print the document, which can be accessed by clicking on the link below, and hand it out to all ellaOne® users to inform them about the existence of the pregnancy registry and the collection and processing of their personal data.

In case a pregnancy exposed to ellaOne® occurs, you can also advise your patient that she can participate in the pregnancy registry on her own, by accessing the pregnancy registry website directly.

Click here to download information on the pregnancy registry to be given to your patient.

How is patient's confidentiality ensured?

Patients' and babies' identities will not be collected. The pregnancy registry will only collect patients' initials, dates of birth and countries of residence, that will allow HRA Pharma to obtain information on a patient correctly identified when contacting health care professionals. Information on initials, date of birth and country of residence is only asked for to facilitate the follow-up of the pregnancies. The information collected in the registry will not be sufficient to identify patients.

How can you participate?

When you are advised that one of your patients has been inadvertently exposed to ellaOne® during her pregnancy or has become pregnant despite having taken ellaOne® following unprotected intercourse, you are encouraged to report prenatal exposure to ellaOne® during pregnancy with the agreement of your patient by completing the Enrolment form as early as possible to facilitate the collection of prospective and unbiased information.