BCFS00925-OHSU-Edelman-HealthyVolunteer [Landing Page] -

Healthy Volunteer Research Study

The Women’s Health Research Unit at OSHU is investigating a vaginal birth control ring that may also help prevent sexually transmitted infection.

Fast Facts

Study Background

The Women’s Health Research Unit at OHSU is investigating a vaginal birth control ring that may also help prevent sexually transmitted infection. This study is not testing if the study ring works to prevent pregnancy or sexually transmitted infection. We are looking at whether the ring is safe and well tolerated; in addition, we will gather information about how the medications are circulated through the body when the ring is used for three months.

The study medications are released via a self-administered vaginal ring. The ring contains levonorgestrel (a type of progestin used in many currently approved birth control methods) and dapivirine (an investigational medication being developed to prevent HIV). The study is looking at two different doses of the study drug by randomly assigning participants to one combination or the other.

Additional Information

Why is this study being done?

In this research study, we want to look at how the study drugs are circulated through the body, to find out if the ring is safe and well-tolerated, and to look at the effects of the ring on vaginal bleeding.

Is this study for me?

You may qualify for a study if you meet the following criteria.

Inclusion Criteria:

Are between ages 18 to 45
Were assigned female sex at birth and are not currently on female-to-male transition therapy
Are protected from pregnancy by non-hormonal contraception, or not at risk for pregnancy (e.g copper IUD, condoms, abstinence, sterilization, same-sex partner)
Are in general good health
Have a regular menstrual cycle (21-35 days)

What will happen if I participate in the study?

Participation in the study will last approximately six months. This includes three months of active ring use, screening procedures, and up to four phone contacts in the three months following ring removal. There will be 14 in-person clinic visits. Participants may have a virtual visit prior to the first clinic visit to review the informed consent form. The most frequent study procedures include blood draws and pelvic exams. Depending on the visit, procedures will also include medical history review, vitals collection (e.g. blood pressure, height, and weight), physical exams, breast exams, urine pregnancy tests, and STI screening. During study participation, participants will be asked to complete a daily paper diary documenting vaginal bleeding and sexual intercourse.

Will I be paid for being in this research study?

Yes, participants will be compensated up to $695 for completing all parts of the study.

Will it cost me anything to participate in this study?

There is no cost for you to participate in our research study.