The goal of this study is to learn how well the hormone-free intravaginal disk, Ovaprene®, prevents pregnancy in women who can become pregnant.

You may qualify if you meet the following criteria.

Inclusion Criteria:

• Sexually active women ages 18-40
• Interested in using a hormone-free birth control (and willing to get off other forms if applicable)
• Have regular menstrual cycles
• In good general health
• Not actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy
• In a relationship with a person assigned male at birth who is 18 years or older, and not known to be infertile or subfertile
• Willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle
• Be willing to use Ovaprene as the sole method of contraception for the course of the study
• Not currently pregnant, breastfeeding, or planning on becoming pregnant
• No history of suggestive infertility, endometriosis, or pelvic inflammatory disease
• No history or risk of HIV
• No history of toxic shock syndrome or hereditary hemochromatosis
• No dependence on substances such as alcohol or other drugs

Participation in this study will last approximately 13 months, and include 8 in-person study visits and 2 telephone study visits. Participants will also be asked to complete a daily electronic diary documenting their menstrual period, sexual intercourse, use of vaginal products, use of medications, and any problems with Ovaprene®.

Participants will use the intravaginal disk Ovaprene®, a device consisting of a round piece of woven material surrounded by a soft, flexible rubber ring. This device is inserted at the end of the period, and worn until the start of the next cycle. During this time, materials are slowly released to create an environment that makes it more difficult for sperm to be mobile. 

Study procedures include

• Medical history review
• Physical exam
• Pelvic exams
• Vitals sign collection
• Blood draws
• Pregnancy tests
• STI screening
• (Optional) Vaginal swabs
• (Optional) Colposcopy exams

Ovaprene® is an experimental device which has not been approved by the United States Food and Drug Administration (FDA).

As a participant, you can receive up to $1,614 for your time and effort.

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