CCN019B Study

STUDY BASICS

Are you between 18 and 45 and willing to use an investigational vaginal ring? This ring contains 2 drugs, dapivirine and levonorgestrel and is not used to prevent pregnancy in this study.

STUDY PURPOSE

The purpose of the study is to find out how the two drugs, dapivirine and levonorgestrel, enter and exit the body when a vaginal ring containing the two drugs is inserted into the vagina and worn continuously (without being taken out). We would also like to find out more about the acceptability of the ring and its effects on vaginal bleeding. You would be randomly assigned – like flipping a coin – to one of the two rings. The two rings release the contraceptive hormone in the ring at different rates.  

We are hopeful that this study will help develop vaginal rings that can be used to prevent both pregnancy and HIV. 

COULD THIS STUDY BE RIGHT FOR YOU?

• Females aged 18-45 
• Have regular menstrual cycles 
• Using a non-hormonal form of birth control or otherwise not at risk for pregnancy 
• HIV Negative 

WHAT PARTICIPANTS CAN EXPECT

If you enroll, you would be randomly assigned to one of two study rings. You may be asked to complete a daily diary about your use of the vaginal ring and any vaginal bleeding that you experience 

During all visits, blood samples and vaginal fluid would be collected to measure the levels of the study drugs. At day 90 (visit 11), the ring will be removed. The final three visits (visits 12-14) will occur 1, 2, and 3 or 4 days after the ring is removed. All visits will take approximately 1-2 hours. Study staff will call you up to 4 times in the 12 weeks after ring removal to follow up and to see when your periods start again.