Study Evaluating How Well a Non-Hormonal Vaginal Ring Birth Control (Ovaprene) Works
This study wants to find out how well a monthly, non-hormonal vaginal ring is at preventing pregnancy.
Why this Research Matters
Studies show that women want birth control that is easy to use and works well. Many don’t want to take something every day or use it right before or during sex. Almost 85% of women would rather have a once-a-month option with fewer hormones than the daily pill. But non-hormonal methods haven’t changed over time.
What to Expect
If you join this study, you and your partner will only use the vaginal product as your only method of birth control. The vaginal product is called Ovaprene. It’s a soft, flexible rubber ring with a woven center. The ring slowly releases ingredients that make it hard for sperm to move. The ingredients include ferrous gluconate (a type of iron), Vitamin C, glycine and polyglycolide. Ovaprene is meant to provide continuous birth control and is replaced once a month. It is still being tested and has not been approved by the Food and Drug Administration (FDA). You will complete 8 in-person visits and 2 phone calls during the study. At the visits, you will have a physical exam. We will check your blood pressure, heart rate, and body temperature. At two visits, we will take a small amount of blood from your arm using a needle. This helps us make sure that it is safe for you to take part in the study and to test for iron levels and HIV. We will also collect a urine sample and a vaginal swab. These are used to check if you are pregnant and for any infections. You will also be asked to fill out a short daily diary.
Study Duration
You will be in the study for about 13.5 months.
Who can Participate
You may be able to join this study, if you:
- Are a healthy and were assigned female at birth
- Are between 18 and 40 years old
- Can become pregnant and want to use birth control
- Are in a relationship with a someone who was assigned male at birth who meets the study criteria below
- Have regular periods (when not using hormonal birth control) that occur every 21 to 35 days, and don’t have heavy bleeding that lasts more than 5 days
- Are willing to stop using your birth control
- Do not want to be pregnant for at least 13 months and are willing to accept the unknown risk of pregnancy
- Expect to have vaginal sex at least 4 times per month with the male participant during the study
- Are willing to use Ovaprene as the only method of birth control during the study
- At least 18 years old
- Not known to have fertility problems
- Willing to use only Ovaprene for birth control during the study
- Expect to have vaginal sex 4 times per month with the female participant during the study
Study ID
Protocol Number: 23-1580
More information available at ClinicalTrials.gov: NCT06127199
Compensation Information
Meet the Team
Principal Investigator