In 1960, FDA approval of the first hormonal contraceptive—more commonly known as “the pill”—revolutionized sexual and reproductive health, giving women unprecedented control over their fertility for the first time in history. Today, there are a range of contraceptive products available to women across the globe. Of the over 30 MPTs in the product development pipeline, 18 have a contraceptive component combined with protection against select sexually transmitted infections (STIs), including HIV, herpes simplex virus (HSV), and chlamydia. Still, women around the world need more choices. As a woman’s needs change and evolve over her lifespan, having a suite of product options for protection against unplanned pregnancy, HIV, and other STIs remains critical.
MPTs that feature a non-hormonal contraceptive component represent an important part of the prevention landscape as they can be used by women who either cannot or choose not to use hormonal contraceptives. Elevating non-hormonal contraceptives combined with anti-infectives that prevent STIs, including HIV, could be a game changer for female-initiated prevention products.
Non-hormonal contraceptive MPTs have recently risen in prominence in product development and in the public eye, as the majority of women who discontinue their contraceptive method do so as a result of ‘method related concerns.’ Other reasons cited include medical contraindication, sociocultural factors, and a desire for an on-demand method, among others. There are several non-hormonal contraceptive methods available, including barrier methods (e.g., diaphragms, cervical caps, and condoms), copper ParaGard IUD, and several sponges and spermicides. While there are currently no approved non-hormonal contraceptive MPTs, there are nine in pre-clinical stages or clinical trials.
Over the past year, the IMPT Secretariat has been working with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Contraception Research Branch to stimulate growth in the area of non-hormonal contraceptive MPTs. As part of this work, we are identifying strategic actions to advance non-hormonal contraceptive MPTs.* While the focus of this activity is on female-initiated non-hormonal contraceptive approaches, including approaches that can be combined with agents that prevent HIV and other STIs, outcomes are expected to help inform male-initiated non-hormonal contraceptive approaches as well.
To inform strategic actions for non-hormonal contraceptive MPTs the Secretariat began by conducting a landscape review of all female and male non-hormonal contraceptives. This review was informed by a search of relevant projects and research in both the peer-reviewed and grey literature, news articles, funding notices, and databases (e.g., grants.gov), other product databases (e.g., NIH rePORTER, Calliope (the Contraceptive Pipeline Database), and the MPT Product Development Database. We also conducted key informant interviews (KIIs) with more than 30 scientists from around the globe with expertise in non-hormonal contraceptive development, medicinal chemistry, clinical research, as well as infectious disease prevention. These interviews were transcribed and coded, and key themes were identified.
From these key themes have emerged six proposed strategic actions, which were presented for critical review and feedback to a group of nearly 40 contraceptive development and infectious disease experts, some of whom participated in the initial KIIs, at a breakout session facilitated by the IMPT’s Drs. Bethany Young Holt and Anke Hemmerling during the NICHD’s annual Contraceptive Development Meeting.* The meeting, co-hosted by Baylor College of Medicine in Houston, Texas, centered around innovative approaches in contraceptive development—prominently featuring non-hormonal contraceptives, MPTs and male contraceptives.
Building upon the identified action areas, a final set of prioritized strategic actions for advancing non-hormonal contraceptive MPTs will be submitted to a special issue of the journal of Biology of Reproduction which will feature multiple innovative approaches in the non-hormonal contraceptive and MPT spaces. This work builds upon a similar action framework for hormonal contraceptive and HIV prevention MPTs developed by the IMPT and published in The European Journal of Contraception and Reproductive Health Care.
It is our hope that the priority action strategies for advancing non-hormonal contraception will serve as a set of guidelines for the MPT field, directing focus to where work is most needed to bring this important suite of prevention options to women who need them most.
*Note: The forthcoming work described around non-hormonal contraceptive MPTs is a product of the IMPT and does not represent the position of NICHD or the National Institutes of Health (NIH).
This post was also published on the Contraceptive Technology Innovation (CTI) Exchange Blog. CTI Exchange brings together a consortium of global partners to generate and share resources on contraceptive research, development, registration, and introduction.