FAQs

The CRENESSITY Pregnancy Study was created to help doctors better understand if CRENESSITY has any effect on pregnancy, delivery, or the health of babies. All people taking part in this study will have been prescribed CRENESSITY.

People can help by sharing their experiences throughout their pregnancy and information on the health of their babies until they are 1 year old.

At most, you will be contacted by a coordinating center representative:

• when you join the study
• once during each trimester of your pregnancy
• about 4 weeks after you give birth
• when your baby is 3, 6, and 12 months old.

Your healthcare providers will also be contacted up to 3 times during your pregnancy, and once after you deliver. Your baby’s healthcare provider will be contacted when your baby is 1, 3, 6, and 12 months old. You will not be asked to attend extra visits at a healthcare provider’s office or change anything you usually would do. In addition, participation in this study does not change any treatments that you would otherwise receive.

This study is a research study. For the protection of all participants, research studies are reviewed by an Institutional Review Board (IRB). An IRB is a group of scientific and non-scientific individuals who perform an ongoing ethical review of the study with the participants’ rights and welfare in mind. An IRB has reviewed this study. The coordinating center representative will read and review the consent form (also reviewed by the IRB) with you. The consent form explains the study in detail and lets you know your rights. It also outlines your role as a participant in the study. You will receive a copy of the consent form.

The CRENESSITY Pregnancy Study will help doctors better understand if CRENESSITY has any effect on pregnancy, delivery, or the health of babies. Coordinating center representatives will collect information from people who took CRENESSITY at any time during pregnancy and who have classic congenital adrenal hyperplasia. By sharing your experience, you could help other people and their doctors to better understand if CRENESSITY has any effect on pregnancy, delivery, or the health of babies.

No. Participation in this study does not offer direct access to any medical services or advice. It also does not endorse or provide any healthcare product or service. If you have any questions about your healthcare, please talk to your healthcare provider.

People with classic congenital adrenal hyperplasia who took CRENESSITY at any time during pregnancy may be eligible. A coordinating center representative will confirm if you are able to participate in the study.

After you decide that you want to join the CRENESSITY Pregnancy Study, you will give your electronic informed consent. You will then need to answer some questions to see if you are eligible for participation.

If you are eligible to take part, you will be asked to provide additional information about yourself, your health, and your pregnancy. You will be contacted, at most, by a coordinating center representative:

• when you first consent to be a part of the study
• once during each trimester of your pregnancy
• about 4 weeks after you give birth
• when your baby is 3, 6, and 12 months old.

After you give consent, your healthcare providers will be contacted up to 3 times during your pregnancy and 4 times after your delivery. Your baby’s healthcare provider will be contacted when your baby is 1, 3, 6, and 12 months old.

If you join the study, you will not need to make any extra visits to a healthcare provider for your participation in this study. Participation in this study also does not change any treatments that you would otherwise receive.

Your involvement with the study will last for the duration of your pregnancy and until your baby is at least 1 year old.

Your initial telephone interview to provide consent may last about 45 minutes. The follow-up telephone calls that happen once per trimester and after your delivery will each last about 10–15 minutes.

There is no cost to you for joining the study.

Please check with your mobile service provider about any charges that may be associated with receiving text messages. You will only receive texts from the study team if you decide you want to receive reminder messages.

You will not be paid for taking part in the study.

Although it is a good idea to notify your healthcare provider about your participation in the study, their permission is not required.

If you agree to participate in the study, you will give permission to your and your baby’s healthcare providers to share information about you and your baby.

We must collect your personal contact information to send you emails and call you to complete the telephone assessments. We will not store your personal contact information with your medical information. The researchers reviewing medical data will not have access to your personal contact information.

We will use your information for research purposes. We will collect information about your identity, health, and the health of your baby. The information you provide may help researchers gain insight into the use of CRENESSITY at any time during pregnancy.

The information you provide in telephone interviews will not be associated with your name, your baby’s name, or your contact details. Your personally identifying information will not be shared with the Sponsor, of this study. In any presentation of results from this study, your identity will remain anonymous and confidential. The study information is expected to be kept for 15 years and may be kept longer.

Please contact a coordinating center representative at CrenessityPregnancyStudy@iqvia.com or use the toll-free number 1-850-753-8802.

You can change your contact information at any time. Simply click the link in any of our emails to update your contact information. You can also contact the study team at CrenessityPregnancyStudy@iqvia.com or use the toll-free number 1-850-753-8802.

Your participation in this study is voluntary. You may withdraw your consent at any time. If you no longer want to participate, please contact us on the toll-free number 1-850-753-8802.

To learn more about our Privacy Policy and how your information will be used, please visit our Privacy Policy page.

Please contact your healthcare provider with any questions about your pregnancy.