Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci 
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  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    PREGNANCIES BY ACTS OF INTERCOURSE WITH VAGINAL PH MODULATOR: RESULTS FROM THE AMPOWER STUDY (Anaheim Convention Center - 207C) -  Aug 21, 2022 - Abstract #ASRM2022ASRM_933;    
    P3
    This post hoc analysis demonstrates that VPM users had a >99% chance of not getting pregnant at each act of intercourse. IMPACT STATEMENT: When providing counseling to women, these findings may serve as an additional tool to describe the efficacy of VPM to complement the Kaplan-Meier assessment.
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Journal:  Lactic acid, citric acid and potassium bitartrate non-hormonal prescription vaginal pH modulator (VPM) gel for the prevention of pregnancy. (Pubmed Central) -  Aug 11, 2022   
    A non-hormonal prescription vaginal pH modulator (VPM) gel (Phexxi®), with active ingredients lactic acid, citric acid and potassium bitartrate, has recently been approved for prevention of pregnancy in the United States...Spermicides, which improve efficacy of barrier devices, may increase the risk of HIV/STIs. VPM gel provides a new safe, effective non-hormonal contraceptive option, with potential for prevention of STIs.
  • ||||||||||  Twirla (ethinyl estradiol/levonorgestrel) / Agile Therap, Corium, Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Journal:  New Contraception Update - Annovera, Phexxi, Slynd, and Twirla. (Pubmed Central) -  Jul 8, 2022   
    Lastly, Twirla is a transdermal patch releasing ethinyl estradiol and levonorgestrel that offers users an additional option for a user-controlled, combined hormonal contraceptive method without daily dosing; however, prescription is limited to patients with BMI < 30 kg/m due to decreased efficacy and VTE events in people with obesity. The addition of these products expands the available options for pregnancy prevention to address unmet contraceptive needs.
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Characterization of Women Who Experienced Urinary Tract Infections in the Phase 3 AMPOWER Trial (Hall E) -  Mar 31, 2022 - Abstract #ACOG2022ACOG_351;    
    P3
    INTRODUCTION: Vaginal pH modulator (VPM; Phexxi) is a non-hormonal, on-demand, woman-controlled gel for the prevention of pregnancy... Compared to the overall AMPOWER population, women who experienced on-study UTIs had similar baseline characteristics and slightly lower product use.
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Trial completion, Trial completion date:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Nov 21, 2019   
    P2b,  N=860, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Feb 2020 --> Aug 2019
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Enrollment closed, Trial completion date, Trial primary completion date:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Aug 14, 2019   
    P2b,  N=844, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Feb 2020 --> Aug 2019 Recruiting --> Active, not recruiting | Trial completion date: May 2019 --> Feb 2020 | Trial primary completion date: Feb 2019 --> Sep 2019
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Trial completion:  AMP002 Phase III Contraceptive Study (clinicaltrials.gov) -  Aug 14, 2019   
    P3,  N=1400, Completed, 
    Recruiting --> Active, not recruiting | Trial completion date: May 2019 --> Feb 2020 | Trial primary completion date: Feb 2019 --> Sep 2019 Active, not recruiting --> Completed
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Enrollment closed:  AMP002 Phase III Contraceptive Study (clinicaltrials.gov) -  Mar 7, 2018   
    P3,  N=1400, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Enrollment open:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Nov 17, 2017   
    P2b,  N=844, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Enrollment change:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Oct 25, 2017   
    P2b,  N=844, Not yet recruiting, 
    Not yet recruiting --> Recruiting N=634 --> 844
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    New P3 trial:  AMP002 Phase III Contraceptive Study (clinicaltrials.gov) -  Aug 9, 2017   
    P3,  N=1350, Recruiting, 
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    Trial initiation date:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Jul 2, 2017   
    P2b,  N=634, Not yet recruiting, 
    N=634 --> 844 Initiation date: May 2017 --> Oct 2017
  • ||||||||||  Phexxi (citric acid/lactic acid/potassium bitartrate) / Evofem Biosci
    New P2b trial:  Phase 2B/3 Double-blinded Placebo-controlled (clinicaltrials.gov) -  Apr 11, 2017   
    P2b,  N=634, Not yet recruiting,