New Vaginal Gel Contraceptive: Who's It For?

Andrew M. Kaunitz, MD


July 13, 2020

This transcript has been edited for clarity.

In May 2020, the US Food and Drug Administration approved Phexxi gel as an on-demand vaginal contraceptive available by prescription. (Full disclosure: The University of Florida received research funding for clinical trials of Phexxi.)

This gel, which combines lactic acid, citric acid, and potassium bitartrate, is designed to maintain an acidic vaginal environment inhospitable to sperm.

Patient instructions indicate that women should administer one prefilled, single-use applicator — which delivers 5 g of the gel vaginally — immediately before or up to 1 hour before each episode of vaginal intercourse.

In a multicenter, single-arm US clinical trial, 101 pregnancies occurred among almost 1200 participants. Over seven cycles, the cumulative pregnancy rate was 13.7%. This corresponds to an estimated Pearl Index of 27.5 pregnancies per 100 women-years. To put these numbers in perspective, with typical use, the Pearl Index for over-the-counter nonoxynol-9 spermicides is 28.

The most common adverse events noted in the clinical trial were vulvovaginal irritation, yeast infection, and urinary tract infection. Package labeling for Phexxi indicates that this contraceptive gel should not be used by women with a history of recurrent urinary tract infections.

So, which of our patients might be interested in using this new vaginal contraceptive gel?

My sense is that Phexxi will appeal mostly to women who wish to avoid use of hormones, and who are comfortable choosing a vaginal contraceptive with a failure rate comparable to that of available over-the-counter spermicides.

Thank you for the honor of your time. I am Andrew Kaunitz.

Dr Andrew Kaunitz is a tenured University of Florida term professor and associate chair of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine in Jacksonville. Dr Kaunitz has published more than 240 articles in peer-reviewed journals, including The New England Journal of Medicine, JAMA, and Obstetrics and Gynecology.

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