Department is General Surgery, St James' University Hospital, Leeds, UK.
Department of Obstetrics and Gynecology, University of Texas Medical Branch, TX, USA.
Expert Rev Clin Pharmacol. 2022 Jun;15(6):659-670. doi: 10.1080/17512433.2022.2100347. Epub 2022 Jul 21.
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.
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.
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.
一种非激素处方阴道 pH 值调节剂（VPM）凝胶（Phexxi®），其活性成分包括乳酸、柠檬酸和酒石酸钾，最近已获得美国批准用于避孕。本综述旨在汇编已发表的临床前和临床试验的现有证据，以支持其使用。
在 PubMed 上搜索了关于 VPM 凝胶的已发表文献。在 clinicaltrials.gov 数据库中找到了两项 III 期临床试验。结果表明，VPM 凝胶安全，副作用极小，且有效（6-7 个周期累积妊娠率为 4.1-13.65%，（珍珠指数 27.5）作为避孕措施。杀菌作用表明其具有预防性传播感染（STIs）的潜力；目前正在进行一项 III 期临床试验，以评估其预防衣原体和淋病的效果。
非激素可逆避孕选择一直限于高度有效的含铜宫内节育器，该节育器需要由经过培训的临床医生插入，以及效果稍差的与性行为相关的屏障和杀精剂选择，这些选择通常可在柜台上购买。杀精剂可提高屏障装置的效果，但可能会增加 HIV/STIs 的风险。VPM 凝胶提供了一种新的安全有效的非激素避孕选择，具有预防 STIs 的潜力。
