New hormone-free contraception method emerges: is it really effective?

[Updated February 2024]

In September 2021, a new method of contraception was released in the United States. Unlike the birth control pill, Phexxi, which has been approved by the Food and Drug Administration (FDA), is a hormone-free contraceptive. This new method of contraception has many advantages.

Unlike spermicides, this gel does not destroy cell membranes or introduce chemicals that can damage the mucous membranes lining the vagina. Unlike condoms, it does not impact sexual comfort by reducing sensation during intercourse. Its approach to preventing unwanted pregnancies is new - and potentially very interesting - especially for women and people with vaginas who are concerned about the health problems associated with hormonal contraceptives such as the birth control pill, implant, vaginal ring etc. which make up the bulk of the offer on the market today.

What is this new non-hormonal contraception?

Phexxi is described as "a prescription, hormone-free vaginal gel that has been approved by the FDA to prevent pregnancy, and you use it only when you need it, which is during intercourse during your fertile window." It is made up of three active ingredients: lactic acid, citric acid, and potassium bitartrate. Three harmless ingredients that do not affect vulvovaginal health in particular or other organs in general, and which contribute 93% to preventing unwanted pregnancy.

The method of application is simple. The gel is injected into the vagina using an applicator, before intercourse. This combination of ingredients is designed to ensure that the gel remains in the vagina during intercourse for approximately 1 hour, with the aim of maintaining the vaginal flora at its natural pH between 3.5 and 4.5. Since the pH of the vagina increases when sperm is introduced, keeping it at its natural acidity level prevents sperm from swimming more efficiently towards the eggs, if they have been released. This is called reducing sperm motility.

How effective is Phexxi and does it have any side effects?

This new contraceptive has a 93% effectiveness rate with perfect use in clinical trials, as well as an 86% effectiveness rate with typical use. This places Phexxi between the condom (87%) and the diaphragm (83%) in terms of effectiveness. It is very important to note, however, that Phexxi does not provide protection against sexually transmitted infections.

According to the manufacturer's website, less than 2% of women in clinical trials stopped using the drug due to various side effects, the most common being vaginal burning and itching. It is also recommended that Phexxi not be used in people "with a history of recurrent urinary tract infections or urinary tract abnormalities."

A total of 2,480 women used Phexxi in the two studies used for FDA approval. Over 7 menstrual cycles, 18% reported burning of the vulva and vagina, 14% itching, 9% yeast infections, 9% UTIs, and 8.4% bacterial vaginosis. About 10% of male partners reported irritation, mostly minor. As Canadian gynecologist Jen Gunter notes, “There was no placebo gel group for comparison because it would be unethical to give women a placebo contraceptive, so we don’t know if the rate of bacterial vaginosis and UTIs with Phexxi was higher than the average for a group of sexually active women of childbearing age or not.”

Will the efficacy and side effect rates be maintained over time as more people begin to access the drug? We will have to wait until the product has greater adherence.

Phexxi has several advantages over other contraceptives when it comes to side effects and usage. Unlike the pill, it does not affect the user's hormones and does not cause headaches. And unlike IUDs (Intrauterine Devices: coils), it does not (and certainly should not) cause any pain during insertion. Since it only needs to be applied before intercourse, there is less reason to worry about the risks of long-term effects or to monitor its daily use. Phexxi can be used throughout the menstrual cycle, even during menstruation and during the postpartum phase (after giving birth).

FDA accuses Evofem of false marketing…

Recently, the Food and Drug Administration (FDA) raised concerns about Evofem’s marketing of Phexxi after reviewing a digital patient brochure. In the brochure, Evofem claims that “99% of pregnancies per act of intercourse are prevented” and that “Phexi prevents pregnancies 99% of the time.” These claims raised alarm bells at the FDA , which was quick to remind Evofem in a letter that “the likelihood of a sexual act resulting in pregnancy varies depending on the timing of intercourse relative to ovulation.”

What do people who have used this new method think?

With an average rating of 4.9 out of 10 and a total of 26 opinions on Drugs.com shared by Phexxi users:

It is noted that only 42% of people who tried this method of contraception had a positive experience, while 58% reported a negative experience, including unwanted pregnancies! We can read reviews like: " I have been using it for a few months and have not been pregnant. I am very happy with how easy it is to use and how well it works without the use of hormones. I was getting very depressed while using the pill, so I had to stop using it. I have had no side effects with Phexxi and I only use it when I need it ", or:

“ I used this product as a birth control method because hormones weren’t working for me. I was very excited when I heard about Phexxi. My husband and I used it for about 6 months. I was careful and used it as directed, but eventually I got pregnant. This product should not be on the market, especially after Roe V Wade was overturned. It is not a reliable birth control and women should avoid it, especially if they don’t want to get pregnant. I feel sorry for any woman who receives or uses this product and lives in a state where they can’t get the medical help they need when this product fails them, as it did for me . ”

So the opinions remain really mixed…

On the website webmd.com , the rating given to Phexxi is 3.2 out of a total of 111 opinions:

We can observe that 48 users voted that they are not satisfied with this new method and 50 others doubt its effectiveness, we can read opinions like:

Or again:

"I had Nexplanon but wanted something without hormones. I decided to try Phexxi and I regret it. I usually do a ton of research before using something but I went into it blindly. I ended up in the ER with a ton of abdominal pain and what felt like a ton of inflammation that hurt my back and side. I'm taking time off work to deal with these horrible issues. Shame on you Phexxi!!!!!!"

Although there are also some positive reviews, on both platforms we see that a large number of users doubt its effectiveness...

When will this new contraception be available in Europe?

Unfortunately, no European market launch date has been announced yet. Nothing has been officially published to date and the authorization process requires clinical trials and considerable time. We contacted Phexxi officials to get a better idea of ​​its availability and their response does not provide us with more information on the availability of this hormone-free contraception in Europe. They still hope to be able to sell as soon as possible on our continent.