Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Women’s Health Clinical Research Center at University of Pennsylvania
Location: Philadelphia, PA, USA
Lead Doctor: Kurt Barnhart, MD
IRB Committee: This study has been reviewed and approved by University of Pennsylvania Institutional Review Board

Background

According to the Centers for Disease Control and Prevention (CDC), almost every woman in the United States will use contraception at some point in her life. One of the many methods of contraception is the vaginal ring. The product being tested in this study is Annovera® (segesterone acetate and ethinyl estradiolvaginal system). It is a contraceptive vaginal ring that is FDA-approved. Annovera® releases hormones into the body to prevent pregnancy for women of reproductive potential.In this study Annovera® is not being studied as a form of birth control.  

Researchers are conducting this study to further understand  this method of birth control. The purpose of this study is to find out if using tampons and Annovera® at the same time affects the amount of hormone released into your blood from Annovera®.

Interested participants must be between age 18-35 who have an intact uterus with both ovaries and are sterile or able to become pregnant.   They must not be currently pregnant or actively trying to become pregnant. Participants must attend 23 study visits over approximately 4 ½ months.

Why Participate? 

• There are no direct benefits to you for participating in the study,
• You may get more information about your own health by participating.
• You will be able to talk to the study doctor about your health and healthcare.
• You may have the opportunity to try an FDA-approved contraceptive method.
• You may help researchers evaluate this new product by contributing valuable information through participation.
• You may be helping other women in the future.
• You may be helping to advance research on women’s health.

Your Rights

• If you decide to participate in the 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, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Healthy women ages 18 to 35 years old who have an intact uterus with both ovaries.
• Must not be currently pregnant, breastfeeding or actively trying to be pregnant. 
• Must have a regular menstrual period (menstrual period every 21-35 days).
• Able to attend 23 study visits at the research site over approximately 4 ½ months as well as be willing to comply with the following study requirements.
  • Please note that the study visits will take about 30 minutes to 1 hour to complete.
    • There will only be 2 study visits which will take about 12 hours. However, participants can still do their daily activities (such as work remotely, etc.) while attending these 2 study visits.
  • Willing  to use oral contraception a month prior to using Annovera®
  • Willing to only use tampons according to the study’s instructions
  • Willing to abstain from sexual intercourse during tampon use

Please note:

Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:

• The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
• The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
• Hand sanitizers are available at the research site.
• The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
• Any staff suspected to have COVID-19, or who has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
• Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
• Pay parking is available at the research site.
• The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. 
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants. 
• COVID19 protocols may vary per location and change at any time during the study to assure the health and safety of patients, staff and broader communities.