TY - JOUR
T1 - Lactic acid, citric acid, and potassium bitartrate non-hormonal prescription vaginal pH modulator (VPM) gel for the prevention of pregnancy
AU - Su, Shanna
AU - Vincent, Kathleen L.
N1 - Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022
Y1 - 2022
N2 - Introduction: 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. The objective of this review is to compile the evidence available from published preclinical and clinical trials to support its use. Areas covered: PubMed was searched for published literature on VPM gel. Two Phase III trials were found on clinicaltrials.gov database. The results demonstrated that VPM gel is safe, with minimal side effects, and effective (cumulative 6–7 cycle pregnancy rate of 4.1–13.65%, (Pearl Index 27.5) as a contraceptive. Microbicidal effects suggest potential for the prevention of sexually transmitted infections (STIs); currently a Phase III clinical trial is being conducted to evaluate prevention of chlamydia and gonorrhea. Expert opinion: Non-hormonal reversible contraceptive options have been limited to the highly effective copper-releasing intrauterine device that requires insertion by a trained clinician, and less effective coitally associated barrier and spermicide options which are typically available over-the-counter. 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.
AB - Introduction: 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. The objective of this review is to compile the evidence available from published preclinical and clinical trials to support its use. Areas covered: PubMed was searched for published literature on VPM gel. Two Phase III trials were found on clinicaltrials.gov database. The results demonstrated that VPM gel is safe, with minimal side effects, and effective (cumulative 6–7 cycle pregnancy rate of 4.1–13.65%, (Pearl Index 27.5) as a contraceptive. Microbicidal effects suggest potential for the prevention of sexually transmitted infections (STIs); currently a Phase III clinical trial is being conducted to evaluate prevention of chlamydia and gonorrhea. Expert opinion: Non-hormonal reversible contraceptive options have been limited to the highly effective copper-releasing intrauterine device that requires insertion by a trained clinician, and less effective coitally associated barrier and spermicide options which are typically available over-the-counter. 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.
KW - Citric acid
KW - lactic acid
KW - non-hormonal contraception
KW - potassium bitartrate
KW - topical vaginal contraceptive
KW - vaginal pH modulator (VPM) gel
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U2 - 10.1080/17512433.2022.2100347
DO - 10.1080/17512433.2022.2100347
M3 - Article
C2 - 35802958
AN - SCOPUS:85134691667
SN - 1751-2433
VL - 15
SP - 659
EP - 670
JO - Expert Review of Clinical Pharmacology
JF - Expert Review of Clinical Pharmacology
IS - 6
ER -