Journal of Sexual Medicine Publishes Sexual Satisfaction Data Involving Phexxi® from Evofem’s Phase 3 AMPOWER Clinical Trial
- 88.7% of Women Using Phexxi® (lactic acid, citric acid, and potassium bitartrate Vaginal Gel) Improved or Maintained their Sex Life According to Exploratory Data Collected During the Phase 3 AMPOWER Clinical Trial
- Women in the Study Provided Data Measured by 10 Variables Ranging from the Ability to Climax to Interest in Having Sex
- Phexxi is FDA Approved to Prevent Pregnancy
SAN DIEGO, April 19, 2022 /PRNewswire/ — Evofem Biosciences, Inc., (Nasdaq: EVFM) today announced the Journal of Sexual Medicine, a peer-reviewed medical journal, published data collected from Evofem’s Phase 3 AMPOWER clinical trial. Analysis of exploratory endpoints shows that 88.7% of women using Phexxi® (lactic acid, citric acid, and potassium bitartrate) reported improvement (n=44.7%) in or the maintenance (n=44%) of their sexual satisfaction. The publication can be found here: https://www.jsm.jsexmed.org/article/S1743-6095(22)00831-1/fulltext
“Phexxi offered the women in this study a non-hormonal, woman-controlled, on-demand contraceptive gel that clearly provided a unique set of positive benefits on their sexual health and enjoyment,” said Dr. Todd Chappell, a clinical investigator and practicing obstetrician and gynecologist. “Publishing these data provides people and their health care providers with information about the impact Phexxi can have on sexual satisfaction.”
The AMPOWER study enrolled healthy women between 18 and 35 who were sexually active with regular cyclic menses. More women reported satisfaction with Phexxi compared to their previous birth control method, and more than 93% percent of women in the study said they were likely to recommend Phexxi.
Investigators leading the trial asked 1330 women questions related to sexual satisfaction in the study. Specifically, patient-reported outcomes related to sexual satisfaction derived from the following:
- A question related to the impact of the previous/current contraceptive on a woman’s sex life
- 10 questions from the Sexual Function Questionnaire related to the frequency of ten sexual problems
- 19 questions from the Female Sexual Function Index related to lubrication
The Phase 3 AMPOWER clinical trial primarily sought to determine the ability of Phexxi to prevent pregnancy in 18 to 35-year-old women. In this trial, women’s sexual satisfaction was listed as an exploratory endpoint, with the post-hoc exploratory analysis of sexual satisfaction.
“The AMPOWER study provided first-time insights on several issues related to sexual and reproductive health, and Evofem is grateful to all those who participated in our trial,” said Saundra Pelletier, Chief Executive Officer, Evofem. “Intimacy is about so much more than reproduction. These data allow us to understand insights into women’s sexual health and sexual satisfaction with the hope of ultimately improving their intimate experiences. Evofem will continue the research necessary to further scientific discourse and seek new and better ways to enhance sexual and reproductive health.”
Phexxi is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
Important Safety Information
- Rare cases (0.36%) of bladder and kidney infections have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi.
- Contact your healthcare provider if you are experiencing genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection, or bacterial vaginosis.
- Phexxi does not protect against sexually transmitted infections, including HIV.
For more information about Phexxi, talk to your healthcare provider and see full Product Information at www.phexxi.com.
Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for United States residents only.
About Evofem Biosciences
Evofem Biosciences, Inc. (Nasdaq: EVFM) is developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from chlamydia and gonorrhea. The Company’s first FDA-approved product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
This press release includes “forward-looking statements” within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, including market and other conditions, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could impair the value of Evofem Biosciences’ assets and business are disclosed in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 10, 2022. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.
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