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New Non Hormonal Birth Control Gel

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The Latest In Contraceptives For 2022

Pregnancy Prevention

A presentation at the 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting discussed the recent updates in contraceptives including new nonhormonal intrauterine devices.

The latest and greatest in contraception, including new nonhormonal intrauterine devices and male birth control, was discussed during a presentation on updates in contraception at the 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting held in San Diego, California from May 6-8.1

Kathleen Morrell, MD, MPH, director of Family Planning Division and residency program director in the Department of Obstetrics & Gynecology at Maimonides Medical Center in Brooklyn, New York, first outlined the IUDs that were just approved for use extension by the US Food and Drug Administration .

This includes Mirena , which was approved to prevent pregnancy for up to 7 years by the FDA on August 11, 2021. Previously, Mirena was approved for use for up to 6 years. The approval was based on the Mirena Extension Trial, a multicenter study investigating the efficacy in preventing pregnancy, as well as treating heavy menstrual bleeding. Bayer plans on seeking approval for use for up 8 years.

Another IUD that was recently given approval for extended use is Liletta , which is now approved for up to 6 years and is expected to see a 7-year approval relatively soon.

Whats new on the market

Whats in the pipeline?

Who Should Not Use Phexxi

Although Phexxi can be used with other birth control methods, or with vaginal fungal infection treatment, it should not be used in combination with a vaginal ring, such as NuvaRing.

Females with a history of urinary tract infections or abnormalities should discuss the risks of Phexxi with their healthcare provider. Phexxi can cause cystitis , pyelonephritis , and other types of urinary tract infections.

Phexxi should not be used for prevention of pregnancy after intercourse. It should only be used before intercourse, as instructed. It does not protect against STIs.

It is not known whether Phexxi passes into breast milk, so consult with your provider if you are breastfeeding.

If You Decide To Use Vaginal Contraceptive Gel

If you decide to try vaginal contraceptive gel, make sure you understand exactly how to use it. Your doctor should tell you the following:

  • You need to use a single dose before each time you have vaginal intercourse.
  • If you use it and then end up having sex more than an hour later, use another dose.
  • You should ask your doctor if you feel like itâs causing you severe or lasting irritation.
  • Contact your doctor also if you think you might have a UTI or other infection.
  • Stop using it if you notice a worrying reaction. In rare cases, you could be hypersensitive to it.
  • Vaginal contraceptive gel wonât protect you from sexually transmitted infections including HIV.

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How To Use Phexxi

Phexxi can be used on its own or in tandem with other forms of birth control, including condoms, diaphragms, spermicide, intrauterine devices , and the Pill. However, Phexxi should not be used with vaginal rings like the NuvaRing, according to the FDA.

Phexxi’s ingredients are non-toxic and commonly found in food products. Lactic and citric acids are natural preservatives, and potassium bitartrate is better known as cream of tartar used in baking. That means it is safe to engage in mouth-to-vulva oral sex while using Phexxi. But be warned, Phexxi is acidic and has a very tart taste.

Phexxis Cost Is Comparable To Other Prescription Birth Control

MucoGYNE® Gel intime non hormonal

Right now, the cost is set between $250 and $275 for a box of 12 prefilled applicators. Evofem predicts that most women will refill their prescription approximately six to seven times per year, which is in the same price range as the monthly method of contraception on a yearly basis. Without health insurance coverage, this works out about $23 per application.

Evofem says it is working to have Phexxi covered under the Affordable Care Act . The ACA mandates that private health plans provide coverage with out-of-pocket costs for one treatment per class in each of the classes identified by the FDA for women in its Birth Control Guide.

Women who dont have health insurance coverage may be eligible for a copay assistance program through the manufacturer.

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A Word From Verywells Medical Expert Board

Phexxi is a new vaginal gel contraceptive. It is female-controlled and on-demand, meaning you only use it when you need it. Many women may like the fact that it is non-hormonal. This means it may have fewer side effects. But if you decide to try it, know that it is probably not as effective as IUDs or the pill. It also will not protect against STIs.Anju Goel, MD, MPH

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Effectiveness Of Nonhormonal Birth Control Gel

When used as directed by a medical professional, Phexxi is 93 percent effective, according to the company. But in typical use , its effectiveness drops to 86 percent.

That means it may not work for roughly 14 out of every 100 people who use Phexxi as their sole method of birth control.

Nonhormonal birth control gel has a higher effectiveness than that of a male condom, female condom, or spermicide, per the FDA . However, its less effective at preventing pregnancy than oral contraception, the patch, shots, IUDs, or surgical sterilization.

Using Phexxi with some other types of birth control can make the gel more effective, though. While it cant be used with vaginal rings, it can be used with:

While Phexxi doesnt come with the same side effects as hormonal birth control, it does have certain risks.

The most common side effects of the nonhormonal birth control gel include:

  • vaginal burning, itching, or discomfort
  • yeast infections
  • bacterial vaginosis
  • vaginal discharge

In clinical studies of the gel, a few cases of bladder and kidney infections were reported, one of which was serious.

With that said, side effects are uncommon, and when they do happen, they tend to be mild. Fewer than 2 percent of participants in clinical trials stopped using Phexxi due to an adverse reaction, according to the manufacturer.

You should not use Phexxi if you or your partner are allergic to the birth controls ingredients, which include:

Do I Need A Prescription To Get Phexxi

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In short, yes, Phexxi is a prescription drug much like most birth control pills. However, you dont have to trek your doctors office to get the prescription. You can fill out a questionnaire on the Phexxi website, then youll be connected via a telehealth appointment with a board-certified doctor who will ask you questions to determine if Phexxi is right for you if so, theyll send the prescription right to your preferred pharmacy. Super easy.

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What Are The Benefits Of Hormone

Birth control containing the hormone estrogen can increase your risk of blood clots, stroke, and high blood pressure, and has been linked to increased risk of breast cancer andovarian cancer. With hormone-free birth control, such as Phexxi, you wont experience any of the side effects common with such contraceptives .

Non-hormonal birth control such as condoms offer protection from sexually transmitted infections like gonorrhea and chlamydia that hormonal options dont protect from. Though they dont protect you from STDs, non-hormonal IUDs can be used long-termfor 3-12 years.

Alternative Contraception Methods That Address Birth Control Risks

One alternative to the above hormonal methods of birth control is a non-hormonal, copper IUD. This type of IUD relies on copper instead of hormones to prevent pregnancy. The birth control risks associated with this type of IUD include severe premenstrual cramps, heavy bleeding, and spotting between periods. You may also be more likely to expel this type of IUD if you have never been pregnant or suffer from heavy menstrual cramps.

There are also several more natural alternatives to consider.

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Does Phexxi Have Any Side Effects Or Risks

According to the FDA, the following symptoms or conditions are listed as potential side effects of using Phexxi:

  • Vaginal burning
  • Vulvovaginal pain

Phexxi isn’t perfect, and experts are particularly concerned about the 86% effectiveness.

“It doesn’t give ideal contraception, so if you are going to be having frequent intercourseand particularly if you are a young fertile womanI would suggest speaking with your health care provider to get a more effective contraceptive,” , a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School, told Health.

Dr. Minkin noted that more effective non-hormonal birth control options are available, such as the Paragard IUD. Also known as a Copper-T, the IUD is made of copper, which creates a toxic environment for sperm. “It gives them 99% effective contraception, has no hormones, and lasts for at least 10 years,” Dr. Minkin added.

The side effects can also make Phexxi a less-than-ideal choice for some. “Women prone to urinary tract infections or recurrent yeast infections should definitely check in with their doctor,” Dr. Wider said.

Overall, Phexxi adds one more birth control option to the table, which is never bad. “It’s a great addition for women who are seeking non-hormonal methods,” Dr. Wider said. And when more options are available, more women may use them to prevent pregnancy. As Dr. Levitt noted: “Anything is better than nothing.”

How Do You Take It

MucoGYNE® Gel intime non hormonal

You only need to take Phexxi when you need it. It can be taken immediately before or up to one hour before sex.

According to Gersh, Phexxi “requires thoughtful use and preparation,” so it’s best suited for women who are prepared for some level of forethought.

Phexxi, which comes in a box of 12, will only be available through a prescription. If your insurance doesn’t cover it, it will cost about $250 to $275 per box, or $20 to $23 per dose.

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What Are The Benefits Of Non

Because Phexxi works by creating a hostile environment for sperm, it functions differently from hormonal birth control like pills, vaginal rings, and injections, which are intended to stop the ovulation process each month.

“Many women are tired of the existing options that dramatically alter the way the female body functions,” Gersh said. She added that non-hormonal options like Phexxi offer the benefit of not disrupting hormonal rhythms essential for reproductive and metabolic health.

Phexxi also offers the benefit of not relying on male condom use to prevent pregnancy.

“The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used only when they need it,” Saundra Pelletier, CEO of Evofem Biosciences, said in a statement.

Natural Methods Of Contraception

Natural methods or fertility awareness methods of contraception include rhythm, symptothermal, cervical mucus observation and basal temperature methods. They are based on you monitoring your bodily signs daily , such as changes to your bodys temperature and to your vaginal fluid. This is to determine when you are potentially fertile during your menstrual cycle.Practising natural methods of contraception requires you to abstain from sex when you could get pregnant. Depending on your menstrual cycle, you may need to abstain from sex for up to 16 days.Fertility awareness methods are not recommended in some circumstances for example if you:

  • have a fever, vaginal infection or polycystic ovary syndrome
  • regularly travel through different time zones
  • are under stress.

The effectiveness of natural family planning varies, depending on which method or combination of methods is used.

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A Word From Verywell’s Medical Expert Board

“Phexxi is a new vaginal gel contraceptive. It is female-controlled and on-demand, meaning you only use it when you need it. Many women may like the fact that it is non-hormonal. This means it may have fewer side effects. But if you decide to try it, know that it is probably not as effective as IUDs or the pill. It also will not protect against STIs.” Anju Goel, MD, MPH

Apply Phexxi Up To One Hour Before Sex

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Phexxi is self-administered intravaginally one hour before intercourse. If there is no vaginal sex within the hour of using Phexxi, you must insert a new Phexxi prefilled applicator before intercourse.

Warning: Phexxi does not prevent pregnancy when used after sexual intercourse.

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Birth Control Options For Women Who Cant Use Hormones

Although they are popular, not every woman can use, or wants to use, the pill or other hormonal contraceptive for birth control.

  • Some women cannot use hormones at all because of health reasons, breastfeeding, side effects or a host of other reasons.
  • Some may only need occasional pregnancy protection and prefer not to use a full-time birth control method.
  • Certain women prefer to avoid hormones in general based on personal beliefs.

There are several birth control options that do not contain hormones, that are effective if used correctly, and that are usually affordable, or even free.

A Different Nonhormonal Birth Control Option

Until recently, people seeking hormone-free birth control have found few options available. The most effective and long-lasting nonhormonal option is the copper intrauterine device . Barrier methods sometimes are paired with spermicide to boost pregnancy prevention rates, or spermicides may be used alone . Apps and tests to track fertile days bring a high-tech sheen to the so-called rhythm method, but most ob/gyns do not recommend these as a way to prevent pregnancy.

Not until 2020 did the FDA approve a new nonhormonal birth control, Phexxi, which came on the market last fall. Should you try it if youre looking for a new option?

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How Does Phexxi Work

“It the bodys own natural, vaginal environment to act as a contraceptive method,” she explained.

She added that Phexxi is “highly viscous,” so it doesn’t leak during sex, and it leaves the body with the sperm and other vaginal fluids.

Phexxi does not protect against sexually transmitted diseases or infections.

Phexxi Is Very Effective When Used As Directed

MucoGYNE® Gel intime non hormonal

Evofem states that the approval of Phexxi was based on data from the AMPOWER trial, a single-arm, open-label trial designed to assess the effectiveness of Phexxi in preventing pregnancy and its safety over seven menstrual cycles of use in women who were using no other form of birth control. The study enrolled approximately 1,400 women at 115 study centers in the United States . Results showed a typical use pregnancy rate of 13.7 percent, which corresponds to an 86.3 percent efficacy rate.Additionally, a subset analysis of 1,003 women evaluated for efficacy in the AMPOWER trial showed that when used as prescribed , pregnancy rates following seven cycles of Phexxi ranged from 90 percent to 93.3 percent efficacy.

For comparison, male condoms are considered about 85 percent effective with typical use and 98 percent effective with perfect use birth control pills are 91 percent effective with typical use, and 99 percent effective with perfect use.

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How Effective Is This Type Of Birth Control

FDA approval for this product is based on a multisite study that enrolled sexually active women ages 18 to 35 . Women who participated had regular menstrual cycles and a single male partner. They agreed to just use Phexxi for birth control except for morning-after, emergency birth control, if necessary and engage in heterosexual intercourse at least three times during each cycle throughout the study.

Results collected over seven cycles show that nearly 14% of 1,183 women who completed the study became pregnant.

Overall, the efficacy rate of Phexxi is 86% for typical use.

Phexxi can be combined with some other forms of birth control to increase the odds of preventing pregnancy. Compared with other nonhormonal birth control methods it seems to be more effective at preventing pregnancy than withdrawal natural family planning barrier methods such as condoms and diaphragms and most spermicides . However, as a nonhormonal option, the copper intrauterine device is far more effective.

How Effective Is Phexxi At Preventing Pregnancy Whats The Pregnancy Rate With Phexxi

When used as prescribed, Phexxi is an effective birth control option. According to the manufacturer, Phexxi may be up to 93% effective at preventing pregnancy when used correctly.

But when Phexxi is used incorrectly, the risk of pregnancy increases. One study found Phexxi to be 86.3% effective for preventing pregnancy. This study may have included results from participants who used the medication incorrectly.

Following your doctors instructions for using Phexxi may help the drug work more effectively. To learn more, see the How is Phexxi used? section below. Your doctor or pharmacist can also advise you on how to use Phexxi.

For more information about the effectiveness of Phexxi, talk with your doctor or pharmacist.

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Does Phexxi Have Side Effects Or Drawbacks

One of the concerns with Phexxi is that it has to be timed an hour or less before sex, which can be hard to plan for. It may be easily forgotten and compliance may be far from perfect, Dr. Sekhon says. It is only 93% effective if timed correctly, so user error is a bit of a concern, though if you trust youll remember to use it before sex, it could be a good option.

There are also some physical side effects of Phexxi to know about. The most common side effects reported in clinical trials were vaginal burning and itching, Dr. Sekhon says. Less commonly, users might experience UTI. Male partners may also notice local discomfort , most of which are mild.

There have been a few cases of urinary bladder infection and kidney infection reported in clinical studies. Dr. Chambers says to avoid Phexxi if you have had repeated urinary tract infections or other urinary tract problems. Of the women who used Phexxi in studies, 1.6% discontinued the clinical trials because of an adverse reaction, per the drugs website.

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