Birth control methods have long been dominated by hormonal methods. Now there’s a new birth control gel without any hormones that will soon be available for those who cannot or choose not to use hormones.
The U.S. Food and Drug Administration (FDA) last week approved Phexxi, a contraceptive gel that maintains the vagina’s pH level, or measure of acidity, during intercourse to make it toxic to sperm. It’s expected to be available to consumers in September.
Phexxi comes in pre-filled applicators that need to be inserted into the vagina no more than an hour before intercourse. (A new applicator must be used for every act of intercourse.)
The approval of a new method of contraception is important because most forms contain synthetic versions of estrogen and progesterone, hormones that regulate the menstrual cycle to block ovulation. Hormonal methods were introduced in the 1960s with the invention of the pill, and other hormonal methods now include the birth control shot, patch, ring, and implant.
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Another form of contraception, intrauterine devices (IUDs), long-acting reversible contraceptives, slow the progression of sperm toward the egg, but all but one type of IUD contain hormones. Barrier method contraceptives, like “male” condoms, internal condoms, diaphragms, and cervical caps, are also nonhormonal forms of birth control—but besides male condoms, barrier methods are rarely used these days.
Hormonal methods are safe for most people and, in fact, have some benefits along with pregnancy prevention, like regulating periods and reducing heavy flow and menstrual cramps, as well as the other physical and emotional symptoms that come with premenstrual syndrome (PMS). They can also be particularly helpful for people who have endometriosis, or experience menstrual migraines, anemia, or premenstrual dysphoric disorder (PMDD), a severe type of PMS. Research has shown people who take birth control pills are 50 percent less likely to get uterine cancer than those who have never taken them, and the effects can last for up to 20 years after they stopped taking the pill.
Hormonal methods are not appropriate for everyone, however. People with high blood pressure or smoke cigarettes are warned against using birth control pills that contain both estrogen and progestin, for example, because of the increased risk of blood clots. People with a history of breast or uterine cancer may be told to avoid some IUDs. And some health-care providers recommend that people with diabetes, heart conditions, or a history of some types of migraines avoid certain hormonal methods.
Over the past decade, there has been a bit of a backlash against hormonal methods that coincides with cultural shifts toward organic food and all things natural. While some of this may be based on legitimate lifestyle choices, much of the criticism of hormonal birth control can be traced back to a 2013 book that used anecdotal evidence and junk science to blame the pill for everything from loss of bone density to depression and a desire for plastic surgery.
In truth, the research on hormonal contraceptives is complicated, as studies can seem to contradict each other. There is some research showing hormonal contraceptives can cause adverse mood effects in people with a history of mood disorders while other research suggests hormonal contraception’s impact on mood is mostly positive.
Phexxi’s nonhormonal contraceptive gel contains the common food additives lactic acid, citric acid, and potassium bitartrate. Evofem Biosciences, the San Diego-based company that makes Phexxi, calls it a “vaginal pH regulator” because it maintains vaginal pH in the normal, acidic range between 3.8 and 4.5 that makes it inhospitable to sperm. Sperm thrive in an alkaline range—between 7 and 8.5 is ideal for motility. (The pH scale runs from 0 to 14.) The vagina’s pH level rises during sex to allow the sperm to swim toward the egg. Phexxi is designed to make sure that doesn’t happen.
In a study of 1,400 women ages 18 to 35, Phexxi was found to be about 86 percent effective on average over seven menstrual cycles. This is similar to the typical efficacy rate of male condoms but lower than that of hormonal methods—especially those, such as the implant, that essentially take user error out of the equation. (Once inserted, the implant is 99 percent effective for five years.) Like condoms, Phexxi has to be used at the time of intercourse, leaving room for error and forgetfulness.
Though there are other contraceptive gels available, they contain spermicide, which prevents sperm from reaching the egg. Spermicides have never been particularly effective on their own (only about 21 percent under typical use) and are most often suggested as a complement to another method such as a condom. Moreover, nonoxynol-9, the ingredient in all spermicides sold in the United States, has been found to be irritating to many people and might raise the likelihood of HIV transmission when used frequently.
The new gel has only been approved for pregnancy prevention but there is some evidence that it might provide protection against chlamydia and gonorrhea, two of the most common bacterial sexually transmitted infections (STIs). A preliminary study by the manufacturer found a 50 percent relative risk reduction in chlamydia and a 78 percent risk reduction in gonorrhea compared to a placebo.
The company is hoping to have FDA approval for Phexxi as a form of STI prevention by 2022. Without insurance, Phexxi will cost between $250 to $275 per box of 12.
There are a lot of contraceptive options on the market, but there is always room for more. The birth control that’s best for each person varies based on their health, relationships, and preferences. A new option—especially one that works for people who can’t or don’t want to rely on hormones—is an important addition to the field.