Q&A: Researchers aim to develop novel contraceptive that also protects against STIs

The NIH Eunice Kennedy Shriver National Institute for Child Health and Development recently awarded an $11 million grant to The Population Council Center for Biomedical Research to develop a novel contraceptive.

Researchers will create the first nonhormonal vaginal multi-purpose technology (MPT) ring, which will act as contraception against both sexually transmitted infections and pregnancy.

Lisa Haddad

“This single product has potential to address a wide range of sexual and reproductive needs including protection against sexually transmitted infections, contraception and support of vaginal health,” Lisa Haddad, MD, MPH, director of Population Council and principal investigator, said in a press release. “Women need more options to manage their changing sexual and reproductive health needs. The nonhormonal MPT ring offers hope of an important new contraceptive option that could provide women with protection from the growing risk of STIs.”

Healio spoke with Haddad to learn more about the contraceptive’s defining characteristics, the study and the future of the device.

Healio: How will this ring be different from existing products?

Haddad: As opposed to the currently available contraceptive rings that are out there, this one has no hormones in it. There are also other attributes of this product that expand the prevention profile beyond pregnancy. It also is designed to protect against sexually transmitted infections, such as gonorrhea and chlamydia, as well as other properties that could help optimize the vaginal microenvironment and reduce the risks for bacterial vaginosis.

Healio: Will this be a long-term solution, or will it be a single-use device?

Haddad: We are aiming for each ring to provide continuous protection for a period of 1 month or 3 months, as long as the ring is in place. Alternatively, this is a nonhormonal product, so to some degree there could be flexibility for people who are looking for intermittent protection. With hormonal contraception, if you do not use it the way that you are supposed to, it can lead to breakthrough bleeding or alterations in your bleeding pattern. A nonhormonal contraceptive should not necessarily have the same profile. So, if you are the sort of individual who has infrequent sex or if you have a long-distance relationship and don't necessarily need protection all the time, you may have that flexibility with this product.

Healio: How does it protect against both pregnancy and STIs?

Haddad: There are a few different active ingredients in this formulation that we are looking at, and each of the different active ingredients have activity against — and sometimes overlapping activity against — different endpoints, such as anti-sperm activity or anti-gonorrhea activity. Additionally, one of the active ingredients has a property to optimize the vaginal pH, and that in itself has protective properties as well.

Healio: What limitations do you anticipate with this device?

Haddad: As a product developer, our goal is to expand choice and give people options that will fit within their lifestyle with a profile that they are looking for in a prevention product. It is not a one size fits all. Recognizing that, our goal is to provide different products for different people.

I think the aspect of it being a user-dependent method, compared with IUDs, implants and other methods that are provider dependent, will ultimately lead to potentially lower typical efficacy for a contraceptive product, just because of the nature of human error. That being said, many individuals want a user-controlled product, so we recognize that as a limitation and a strength of the product.

Healio: Would it be available via prescription or as an over-the-counter product?

Haddad: Our ultimate goal is to reduce access barriers, so our target would be to have this become an over-the-counter product.

Healio: What is the study design?

Haddad: There are several different components in our current program. We have aspects related to formulation and animal testing. We also are looking optimizing the product design to meet the needs of users, so we are evaluating nonmedicated vaginal rings of different compression strength — the bendability of the ring — to see which ones are the most comfortable, which ones are less likely to come out when an individual strains. We are going to be asking questions related to how people want to use the product so we can optimize our product to meet the needs.

Healio: Is there any expectation/timetable for approval and commercialization?

Haddad: In product development, it is not always clear in these early stages how long it will take until the product gets into the hands of users. Our hope is that we can accelerate the development as quickly as possible, recognizing that often there are iterations that may lead to unexpected changes in our timetable.

Healio: Is there anything else that is important to know?

Haddad: In general, these multipurpose prevention products have additional public health benefit in a way that they can enhance an individual's protection against other infections or diseases without necessarily adding an additional burden to the individual, and that many individuals may be at risk without knowing. So, having these additional benefits can ultimately lead to greater public health impact. Also, a nonhormonal method in itself would potentially open up opportunities to provide additional options for individuals who may have limitations or contraindications to hormonal methods and that would enhance choice for these individuals.

Reference:

• Population Council awarded NIH Center Grant to develop first non-hormonal vaginal ring for pregnancy and STI prevention. https://www.eurekalert.org/news-releases/941673. Published Jan. 28, 2022. Accessed Feb. 3, 2022.

For more information:

Lisa Haddad, MD, MPH, can be reached at lhaddad@popcouncil.org.