A review of phexxi-the newly fda approved non-hormonal birth control

Updated 11/19/2020

A non-hormonal birth control was FDA approved May 2020 and I was really excited to dig into what it was all about. With how many women I speak to about the destructive side effects of hormonal birth control I wanted to know if this non-hormonal type was something I could start recommending as an option. It is long over due that we had a safe, reliable, on demand, short acting (immediately reversible), non-hormonal birth control that isn’t condoms, and also doesn’t have a long list of side effects that are harmful to our bodies and sexual health.

Here’s a quick list of the side effects and disadvantages of standard oral hormonal birth control, many that you are probably not even aware are even related to hormonal birth control:

Decreased libido, increased risk of yeast infections, BV infections, UTI’s, hormone mediated vulvodynia, or vestibulodynia, lichen sclerosis, lichen planus, decreased vaginal lubrication, thicker discharge, vaginal atrophy, sexual dysfunction, sexual pain (dyspareunia), decreased vaginal elasticity, immature vaginal epithelium/cells, raised pH levels, depleted beneficial bacteria, vulvar dryness, decreased vaginal or clitoral sensations, fatigue and sleep issues, bone density loss, reduced glucose tolerance and increased risk of diabetes, painful penetration including tampons or menstrual cups, depression and/or anxiety, blood clots even UNDER 35 yrs. old, weight gain, headache, nausea, mood swings, increased blood pressure, intermenstrual spotting, missed periods,.  I know there are more, but this is a review of Phexxi, not the less known and more disruptive effects of hormonal birth control-that’s a different article I’m writing!

Hormonal birth control has many benefits: Preventing pregnancy, regulating periods, help for endometriosis symptoms, acne control, migraine relief, mood stabilizer for some, PMS relief, easing menstrual cramps, lighter periods, less breast tenderness for some, and probably a few more I didn’t mention.  However, for many people, too many, the side effects and disadvantages of using a hormonal birth control greatly outweigh the benefits listed above.

There are people who use hormonal birth control and are just fine but might be looking at different contraception options and want to know what Phexxi is all about, and you know that Healthy Hooha will give you all the details that the other outlets don’t.  As I always say-I just want you to have all of the information in order to make the best decision for you.

Then there are the people in monogamous relationships who may both decide they no longer want to use condoms due to lower STI risk but still want to prevent pregnancy.  Phexxi is a great option in this scenario as well.

But let’s get into what you came here for-the good and bad of this non-hormonal contraceptive!

More specifically, Phexxi is a vaginal pH modulator. Phexxi was an investigational molecule that was not commercially available until September 2020 and the product has been in clinical development for some time (about 20 years) so this is not something that has been developed spur of the moment, much research and work and trials have been performed on this formulation

You may have heard of a product like Nonoxynol-9 or just the term “spermicide”, and you may also have heard how poorly spermicides work, OR that N-9 can cause too much vaginal discomfort.  On top of that there are many studies showing that N-9 can make you more susceptible to STI’s and HIV due to the destruction to vaginal epithelium and inactivation of protective vaginal microbiomes i.e. beneficial bacterial.  N-9 is a classified as a surfactant, which is what most soaps, are and work by interfering with the sperms lipids (an oily or waxy molecule) thus immobilizing them and ultimately killing them by decapitation! N-9 has it’s flaws, and maybe fun visualizations, but it’s what we had available with the technology and medical advances at the time of invention.

Phexxi has changed all of that and is much safer for the vagina and much more tolerated simply due to the ingredients which are:

Active ingredients:
L-lactic acid
Citric acid
Potassium Bitartrate- which is cream of tartar, a byproduct of wine making

Preservative:
Benzoic acid- an organic compound found in many plants

Polymer Thickeners:
Alginic acid- natural carbohydrate that comes from algae in seaweed
Xanthan Gum- a polysaccharide (fermented sugar) and commonly used as a food additive

Inactive ingredients:
Glycerin-natural compound derived from vegetable oil or animal fats, acts as a humectant
Sodium Hydroxide-derived from salt water, is commonly referred to as lye, very safe in small amounts and is used for pH adjustment
Water

The way Phexxi works is by acidifying the vagina and coating the vaginal walls and cervix with an acidic bio-adhesive gel helping to maintain the acidic environment of the vagina making an inhospitable environment for sperm .

Ejaculate fluids will raise the vaginal pH above 6.0 as ejaculate is typically about 7.2-8.0 pH, however sperm are naturally completely immobilized at 5.0 and below.  Healthy vaginal pH is typically 3.5-4.5 depending on what part of the menstrual cycle you are in, this is why during the Ovulatory phase of the menstrual cycle the vaginal pH will rise slightly as the Ovulation Cervical Mucus has a pH of 7.0-this creates an environment that assists sperm travel instead of immobilizing them due to normal acidity levels. The Phexxi gel has a pH of 3.55 and maintains this acidity level in the presence of sperm in a ratio of 1:2 making it an effective spermicide.

So, by having the acidifying gel already inside the vagina when the ejaculate comes into contact with the gel the sperm becomes completely immobilized and then either dies off within a couple hours or remains immobilized due the return of the vaginal environment returning to the preferred pH range until they die.  The amount of gel needed to accomplish the method of birth control isn’t that very much, each pre-filled single dose vaginal applicator is supplied with 5 grams which is just under the size of a quarter spread throughout the whole vagina.

However, the acidifying properties only last  

UP TO 2 hours or until vaginal intercourse is performed

There are some anecdotal reports that say the bio-adhesive gel was seen on the vaginal walls and cervix in study examinations 12+ hours after insertion but pay attention to the wording….it said the gel was seen, not the acidifying birth control properties!

The acidifying properties (the aspects you need to be concerned about to prevent pregnancy) were only seen up to 2 hours after insertion or until vaginal intercourse was performed so you will need to reinsert an additional dose IMMEDIATELY BEFORE OR UP TO 1 HOUR BEFORE each time you anticipate any additional vaginal intercourse and/or insemination. Do Not rely on the fact that you see/may see gel still present, it will not be protective after sex or 1 hour has passed.

Side Note: This is also where my theory of why this product isn’t the greatest at BV control.  There is some data that shows it helps reduce the susceptibility to BV infections and this is due to the acidification of the vagina, however since the acidification only lasts a little while, the gel may not gain much traction in the realm of BV prevention (in my opinion).  Inserting the product every couple of hours will only raise the experience rate of side effects.  Current clinical studies have shown it is almost totally non-effective at treating an ACTIVE infection. I will say, though, that it may be helpful for those who have positive BV test results every month due to the vaginal pH raising above 4.5-5.0 during the ovulatory phase when the egg white discharge creates this higher pH environment in order to be more hospitable to sperm motility and facilitate impregnation.  This cycle can be caused by depleted beneficial bacteria due to genetics, hormone levels, or regular antibiotic use. Essentially, this gel can help prevent BV infections, but it will not cure one. However Evofem is currently conducting trials for a product that uses similar ingredient ratios to acidify the vagina in order to help prevent BV infections and STI’s. I hope they are able to get some traction in this area as it is desperately needed. I have linked to their website below if you want to check out what they have going in the research department.

Some worry that once the 2 hours has passed that sperm will regain their motility and ability to resume swimming towards the egg. Typically vaginal pH won’t rise above 5.0 pH meaning return of sperm mobilization before they die is highly unlikely and not an expected outcome. In the event the ovulatory cervical mucus floods the vagina and elevates the vaginal pH, the sperm is expected to have died off before Phexxi’s acidity has worn off.

If you’re not taking hormonal birth control and actively causing the depletion of your protective vaginal microbiome, and your estrogen levels at the vulvovaginal receptors are doing a good job at feeding the beneficial bacteria thus maturing the vaginal epithelium-then your pH should remain in the proper range and not rise above 5.0 pH.

The pregnancy prevention rates are as follows:

93.3% efficacy rate with perfect use

86.3% efficacy rate with “typical use” 

Another Side Note: A rise in sexual satisfaction with contraceptive use increased 300% when females switched to using Phexxi!

(You may have noticed I like my “Side Notes” and “Tid Bits”! They’re just an easy way to throw in some info that doesn’t really fit anywhere else.)

Side Effects:

The side effects are minor, typically don’t last long, and are relatively infrequent depending on frequency of use-meaning the more often you use the product the more likely you are to develop irritation because, after all, it is an acidifyer.  No complaints were recorded and no vaginal or cervical irritation was seen upon visual or colposcopic examination when Phexxi was applied vaginally once a day for 6 consecutive days. 

However, Twice daily use for 14 days showed a higher rate of mild-moderate irritation.

The adherence to the vaginal walls was much greater than currently available spermicides and other lubes/gels making this another reason Phexxi is a great option as it doesn’t leak out as easily!

The side effects presented are the adverse reactions reported in ≥2% of subjects who used Phexxi in studies 1 and 2 in the U.S. population (n=2480). **

18% Vulvovaginal Burning Sensation
14.5% Vulvovaginal Pruritis (itching)
9.1% Vulvovaginal Mycotic Infection (yeast infection)
9.0% Urinary Tract Infection
9.0% Vulvovaginal Discomfort
8.4% Bacterial Vaginosis
5.5% Vaginal Discharge
4.1% Genital Discomfort
3.1% Dysuria
2.1% Vulvovaginal Pain
**Among subjects who used Phexxi in Studies 1 & 2 only 1.6% discontinued from the clinical trials due to an adverse reaction/side effect.

We can say though that as females we are aware that simply having sex can cause any and all of these symptoms to occur.  As such only 8.1% of the reactions mentioned above were labelled DEFINITELY related to product use due to the fact that many of the reported side effects can happen just by having sex or during certain times of the menstrual cycle.

Yay having a vagina!……

Most side effects occurred immediately following application but this makes sense to me as the product is made up of acidifying agents (acids) that drop your vaginal pH to the low end of our typical range. This means that you may (or may not) experience a little irritation if you are not personally used to a pH down closer to 3.5.

Many of us can tell when we are having naturally occurring acidic discharge days because we are experiencing mild burning and itching-hell this can happen to us if we don’t drink enough water or eat acidic foods!  So all I am saying is that there are so many other products and ways we experience vaginal burning and itching and risk of infections and we still engage and use the products enthusiastically so don’t get turned off by the reported side effects.  Get a couple of tubes and try it yourself before saying it definitely isn’t for you.

Those with vestibulitis/vestibulodynia may experience these side effects more easily as vestibulitis/vestibulodynia make the vestibule more sensitive, but give it a try-depending on what your triggers are you may not notice any increase due to having these conditions.

If you do experience any of these side effects and are feeling too uncomfortable to continue exposure, you can wash Phexxi off the vulva, have a little baking soda sitz bath, maybe slather some organic virgin coconut oil on the area and then you should feel better quickly.  Most of the participants rated the side effects mild-moderate, and as I listed above only 1.6% of participates stopped participating due to the side effects so this says the actual severity of the adverse reactions is very mild.

A tid bit worth mentioning for those who also use a Diaphragm:

Use with a diaphragm in a 6 month trial saw a very small increase in vulvovaginal discomfort and in intramenstrual bleeding but the investigators said this was within the range expected with diaphragm use so there must be irritation caused by using the diaphragm itself separate from Phexxi use, and then adding Phexxi increased the irritation slightly.

Something called IL-8 levels in the study group of diaphragm users were significantly higher by month 6 compared to baseline however “this finding suggests that longer term use of Phexxi with diaphragm use may cause subclinical cervicovaginal inflammation”.
Subclinical means: relating to a disease which is not severe enough to present definite or readily observable symptoms.

IL-8 is a “chemokine” or simply put is a substance that triggers neutrophils (white blood cells) to clean up a site the body believes to have inflammation or an infection.

So while IL-8 levels were higher in diaphragm users it was labeled as subclinical because the cervicovaginal area may have had an increased amount of neutrophils but it didn’t show signs of having inflammation or infection that was cause for concern.

I only wanted to mention this aspect in case there were any avid diaphragm users so they could be aware of the increase in irritation and possibly IL-8 markers but this was only seen with diaphragm users and not others.

Which leads me into another Side Effect of Phexxi: the cellular inflammatory response seen in Phexxi users in general and not just diaphragm users.

“The impact of gel on mucosal immunity was assessed by quantifying what are called cytokines, chemokines, antimicrobial proteins, and antimicrobial activity of genital secretions collected by cervicovaginal lavage (wash) at screenings 2 hours after gel application and on days 7, 14, and 21.” -in the twice daily for 14 days application study.

“While there were no increases in inflammatory *cytokines or *chemokines, concentrations of proteins called *Lactoferrin and *Interleukin-1 receptor antagonist were significantly lower following Phexxi application compared to placebo.”

Let me explain all that…..

*Cytokines and Chemokines are proteins that regulate inflammation and immunity- there were not increases seen in these proteins, that’s a good thing!

*Lactoferrin is an anti-microbial protein- shown to be significantly lowered compared to placebo (not the best news)

*Interleukin-1 receptor antagonist (Interleukin-1ra) is an anti-inflammatory protein- also shown to be significantly lowered compared to placebo (also not the best news)

In the study where the participants were to use Phexxi twice a day for 14 days, inflammatory and anti-inflammatory proteins (all those sciencey names listed above) were looked at to see if they rose above or fell below normal levels. 

What was found was that there were no increases in the inflammatory proteins meaning any inflammation caused by Phexxi was not enough to trigger the body to send out defenses and alert scientists to a rise. Our body experiences minor inflammatory responses every day, all day just living life-totally normal.

However, the anti-microbial and anti-inflammatory proteins were “significantly lower” following Phexxi application compared to placebo.  While it is not fully understood as to why this happens with Phexxi use, it is cause for further investigation so we may fully understand if this will be an issue.

My theory is that due to how lactoferrin works, which very simply put—when there is an infection in the vaginal mucosa, lactoferrin and Interleukin-1ra are increased to act as immune mudulators but if Phexxi’s bio-adhesive acidifying gel is covering the vaginal mucosa creating a “protected” normal pH environment (albeit for a very short amount of time-2hrs) maybe these protective proteins are getting mixed signals about the actual status of any pathogens in the vagina and are incorrectly lowering their concentration.

There were also no significant changes in L. Crispatus or L. Jensenii in either the Phexxi or control groups.  I would expect this to be the case as the vagina typically is acidic in the range of the Phexxi product and means that the other ingredients are not affecting the beneficial bacteria concentrations either.  This is really good news as so many things we use for vaginal health negatively affects our vaginal beneficial bacteria.

The need to apply (or reapply) the gel within 2 hours of intercourse, the brief duration of activity, and the potential to develop genital irritation may turn some people off from using this spermicidal birth control but these minor inconveniences are nothing in comparison to hormonal birth control side effects in those that experience them.

Male usage reports:

Male subjects were instructed to apply for 7 consecutive days, 2 mL to the penis at bedtime (the prescription for vaginal insertion is only 1 mL).  The male subjects were then to wash it off 6-10 hours later and record any symptoms on a diary card. 

They were also instructed to not engage in intercourse even with a condom, or any activity that may cause trauma to the penis including masturbation.

24 men ( 12 circumcised, 12 uncircumcised) had this to report:

  • 1 male reported tingling
  • 1 male reported dryness
  • Gel consistency was the aspect least liked and they didn’t like how long it took to dry-but you don’t want a spermicide to dry too quickly so……

The majority of male users didn’t think they would be able to tell the product was being used so if you think your partner will be able to tell you’ve inserted a quarter sized amount of gel inside your vagina-they won’t.  They’d have to have a very uncommon allergy or other dermatological issue like psoriasis of the genitals to even notice any difference.

Storage and contamination of the product:

Per request by Evofem Biosciences that I include in this article Phexxi should be stored in the original foil pack at room temperature, 20 deg C to 25 deg C (68 deg F to 77 deg F) excursions permitteed between 15 deg C and 30 deg C (59 deg F to 86 deg F). Phexxi should not be used after the expiration date stated on the product packaging.

As with anything that comes into contact with your genitals, wash your hands before use so you don’t touch the applicator and then insert it into your vagina.

Stored gels passed the microbial test at all evaluation time points, producing no microbial growth and inhibiting S. aureus, A. niger, C. albicans, E.coli, P. aeruginosa in the microbial challenge tests.

This all means that the product is very stable when kept at room temps even if you prefer a warmer room.  It also showed no growth of the above listed microbes that could contaminate the product and also contaminate the vagina/urogenital tract.

Last but not least regarding this product:

Phexxi, which has been around for about 20 years under different names, has undergone trials for various other things.  One of those things is being a carrier for the HIV prevention medication Tenofovir.

Many studies over the last couple of decades have shown that almost all STI’s and HIV are rendered inactivated at the normal vaginal pH 3.5-4.5.

The hope is that Phexxi can be used to prevent transmission and acquisition of Chlamydia, and Gonorrhea which is undergoing a phse 2b trial in females. It is also being studied combining Phexxi with Tenofovir to better prevent transmission and acquisition of HIV.  It is currently being studied in animal models with good success, but we are a ways away before being approved to be studied on humans.  Other spermicides no only failed to halt the spread of HIV and STI’s, as their main method of action wasn’t acidification of the vagina, but they put the user at a higher risk of contracting/developing an STI or HIV infection due to destruction and inflammation of the vaginal epithelium development of BV infections—Another reason to like Phexxi!

Check out what the makers of Phexxi are working on here:
http://www.evofem.com/in-development/

Phexxi has a 93.3% success rate at preventing pregnancy with perfect use and with how destructive hormonal birth control can be to our body I think Phexxi has the potential to change a significant amount of females lives for the better!

We just have to get the word out. 

We, us, all of us.

We have to get the word out because Big Pharma won’t and if they don’t push the product, clinics and physicians won’t either. Big Pharma doesn’t make money on birth control so they don’t care to put money into research and development.

The pharmaceutical industry funnels only 2% of annual revenue FROM CONTRACEPTIVE SALES back into research and development (of new and better tolerated forms of contraceptives)-according to the Gates Foundation.

“That works out to about $100 million dollars, (that’s) less than 1/6th of what a company might spend to bring a single cancer drug to market!”

But if we start speaking up LOUD AND CLEARLY we can start making our voices heard that we need better non-hormonal options than just condoms.  We need not only the hormonal option to help with endometriosis pain, anemia from high blood loss, acne issues, etc., but we also need more types and more reliable contraceptives that are not hormone based because let’s be honest-we don’t always use a condom when we should and the pill doesn’t work immediately.  Having a gel like Phexxi fills this gap. 

And if you’re worried about the 6.6% chance of becoming pregnant then also practice the pull out method during the ovulatory phase. 

I’m just being real, no apologies! 

Unfortunately there are trade offs, positives, and negatives, of each type of contraceptive because you are attempting to stop an essential bodily function.  So while the other methods have a lower chance of pregnancy risk you are also risking a huge list of side effects by using a hormonal contraceptive or you end up having to go the condom route-which isn’t a bad route but it would still be nice to have more on demand and instantly reversible options.   

You need to consider all the options available and make the best decision for you, I only want to bring you as much information as I can so you have the ability to make the best decision for you and what is happening in your life.

Let’s get the pharmaceutical companies to see the value in creating better contraceptives for females AND males because if you think males are going to put up with the side effects of the male hormonal birth control versions currently undergoing trials……pshhh, not a chance! 

So why should WE?

Help me spread the word about Phexxi so others who may be in need of a non-hormonal, on demand, immediately reversible contraceptive, they know there is an option out there!

https://pubmed.ncbi.nlm.nih.gov/11535216/

https://www.prnewswire.com/news-releases/evofem-biosciences-reports-additional-data-from-phase-3-ampower-study-of-amphora-for-hormone-free-birth-control-300896497.html

https://www.bloomberg.com/news/articles/2019-08-08/better-birth-control-exists-but-big-pharma-isn-t-interested

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3466198/

https://www.researchgate.net/publication/51372184_Postcoital_testing_after_the_use_of_a_bio-adhesive_acid_buffering_gel_ACIDFORM_and_a_2_nonoxynol-9_product

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884999/

https://pubmed.ncbi.nlm.nih.gov/24565736

https://www.researchgate.net/publication/7153582_Vaginal_safety_after_use_of_a_bioadhesive_acid-buffering_microbicidal_contraceptive_gel_ACIDFORM_and_a_2_nonoxynol-9_product

https://pubmed.ncbi.nlm.nih.gov/15914134/

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    and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of
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  1. Thomas MA, et al. A novel vaginal pH regulator: results from the phase 3 AMPOWER
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    nonoxynol-9 and a vaginal contraceptive containing nonoxynol-9. Andrologia. 1981;13:42-49.
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