Woman holding different medicines on the grey background, close-up with no face
She is sick of using birth control, but now is not the right time to get pregnant. The “pull and pray” method is too risky, but she is tired of hormones. Birth control pills wipe out her sex drive. The Depo-Provera shot makes her hungry all the time and causes weight gain. The patch makes her breasts hurt, and she hates the idea of an IUD or implant being inside her body.
She is looking for a nonhormonal contraceptive option where she is in control.
She is not alone. Many women are looking for alternative birth control options. The Food and Drug Administration has approved Phexxi, a new, hormone-free contraceptive gel. This new vaginal on-demand contraceptive option is FDA-approved for the prevention of pregnancy
Phexxi is not a spermicide. It is a first-in-class vaginal pH modulator (VPM) designed to maintain an acidic vaginal pH to reduce sperm’s ability to fertilize the egg. Sperm does not like an acidic environment.
The three active ingredients (lactic acid, citric acid, and potassium bitartrate) keep the vaginal pH in the range of 3.5 to 4.5. This high acidity level creates a toxic environment for sperm and reduces pregnancy risk when used immediately or up to 1 hour before each act of vaginal intercourse.
Phexxi is packaged in a box containing 12 pouches of individual prefilled single-dose applicators. Each applicator contains 1 dose of Phexxi.
Up to one hour before sex, the vaginal gel is self-administered into the vagina like a tampon. The bioadhesive gel is designed to stay in place in the vagina during sex. It will not leak out of the vagina during or after vaginal intercourse, but rather absorbs into vaginal tissue and drains after sex in the mix of semen and vaginal secretions.
Phexxi is not an emergency contraceptive or “morning-after” method. It does not work when used after sex. It must be used before sex occurs, and each applicator may only be used once. If sex occurs again, an additional dose of Phexxi should be applied.
Women may continue to use other forms of hormonal or nonhormonal contraception safely except for the vaginal ring.
The Ampower trial supplied the FDA with data for approval. This study was a phase 3 clinical trial evaluating pregnancy rates in 1384 women aged 18 to 35. Participants in this open-label, single-arm study self-administered a 5g dose of Phexxi intravaginally up to 1 hour before each intercourse episode for up to 7 menstrual cycles.
Pregnancies occurred in 101 women. There were 1183 participants monitored for seven months, equal to 4769 monitored menstrual cycles.
The 7-cycle typical use cumulative pregnancy rate was 13.7% (95% CI, 10.0–17.5), and the estimated Pearl Index was 27.5 (95% CI, 22.4–33.5).
The Pearl index is a commonly used method of comparing various contraceptive options. It is a mathematical formula to calculate the number of contraceptive method failures per 100 woman-years of exposure.
The cumulative pregnancy rate shows that Phexxi is much less effective than long-acting reversible methods such as the IUD and arm implant, but more reliable than the withdrawal method, fertility awareness tracking, or spermicide.
The clinical trials demonstrate women liked using Phexxi. 87% would use it again, and 93% would recommend to a friend.
In the clinical trials, less than 2% of women stopped using Phexxi because of adverse reactions.
9.8% of male partners reported symptoms of penile irritation during the clinical study.
The most common adverse reactions for women were vulvovaginal burning sensation and pain, vulvovaginal itching, yeast infections, urinary tract infections, bacterial vaginosis, vaginal discharge, genital discomfort, and painful urination.
Phexxi is an exciting new addition to the list of available birth control methods. For women who want to avoid hormone exposure, this on-demand method may be an option to explore.
Phexxi does not protect against sexually transmitted infections. Phexxi avoids hormonal side effects and is more effective at preventing pregnancy than traditional spermicide, fertility awareness, and the withdrawal method.
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