Photo: PRNewsfoto/Evofem Biosciences, Inc.
Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced that two new data sets from its Phase 3 AMPOWER trial evaluating Phexxi® (lactic acid, citric acid, potassium bitartrate) will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM). The meeting will be conducted virtually from April 30 - May 2, 2021.
"These new data sets provide clinical insights into how women used Phexxi in the AMPOWER clinical trial as well as their feelings about pregnancy, which are both important factors for clinicians to consider when counseling and prescribing Phexxi," said Brandi Howard, Ph.D., Head of Medical Affairs at Evofem Biosciences.
Both posters will be available to meeting attendees on the ACOG website at https://www.acog.org beginning April 30, 2021, and will be made available in the Posters and Publications section of the company's website at www.evofem.com.
Additionally, the role of vaginal pH modulators in contraception and the contributions of current contraceptive trial design on the "creeping Pearl Index" will be discussed in a Continuing Medical Education (CME) course offered to ASCM attendees. The event is sponsored by an unrestricted educational grant from Evofem Biosciences.
ACOG Abstracts Highlights
Compliance with Vaginal pH Modulator in the Phase 3 AMPOWER Contraceptive Trial
David L. Eisenberg, MD, MPH, FACOG ; Kelly Culwell, MD, MPH; Clint Dart, MS; Brandon Howard, PhD
In AMPOWER, compliance with use was defined as administration of Phexxi intravaginally less than or equal to 1 hour before each episode of intercourse, re-application with additional acts of intercourse, and no use of an additional contraceptive method. Women completed daily e-Diaries to record Phexxi use and coital information. Compliance was calculated based on the percentage of total coital acts reported by each woman throughout the duration of her enrollment in the study.
Of the 1384 women enrolled in AMPOWER, 1330 women reported one or more use of Phexxi, and 1255 women recorded one or more coital acts. Of 32,680 total acts of intercourse, Phexxi was used correctly and as the only contraceptive method, per the study protocol, 84% of the time.
Pregnancy Intendedness with Vaginal pH Modulator: Results From the Phase 3 AMPOWER Trial
Bassem Maximos, MD, MPH; Kelly Culwell, MD, MPH; Clint Dart, MS; Brandon Howard, PhD
Pregnancy intendedness was an exploratory endpoint in AMPOWER. Questionnaires were given at baseline and at subsequent study visits to assess, using a 10-point Likert scale, how participants would feel if they became pregnant. Additional sensitivity analyses investigated correlations between pregnancy intendedness and women's demographic and obstetric history.
Throughout the study, women who completed the questionnaires (1182 of 1384 women enrolled) reported a wide range of feelings about pregnancy, suggesting that efficacy may not always be the most important characteristic with contraceptive use, even when enrolled in a contraceptive clinical trial.
AMPOWER was a single-arm, open-label Phase 3 study designed to evaluate the efficacy and safety of Phexxi in preventing pregnancy. The study enrolled 1,384 women aged 18-35 years across 112 centers in the United States. AMPOWER is the only large-scale, Phase 3 contraceptive clinical trial to include an exploratory endpoint to evaluate the effects of a contraceptive product candidate on women's sex lives.
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to 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 certain sexually transmitted infections (STIs). The Company launched its first FDA-approved commercial product, Phexxi® contraceptive vaginal gel, in the United States in September 2020. The Company's lead product candidate, EVO100, is being evaluated for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women in the ongoing Phase 3 clinical trial, 'EVOGUARD.' For more information, please visit www.evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
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 any sexually transmitted infections, including HIV.
For more information about Phexxi®, talk to your healthcare provider and see full Product Information, which is available at https://www.phexxi.com/themes/custom/phexxiDTC/dist/pdf/PhexxiUSPI.pdf.
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.