关键词: Citric acid lactic acid non-hormonal contraception potassium bitartrate topical vaginal contraceptive vaginal pH modulator (VPM) gel Citric acid lactic acid non-hormonal contraception potassium bitartrate topical vaginal contraceptive vaginal pH modulator (VPM) gel

Mesh : Citric Acid Contraception / methods Contraceptive Agents Female Humans Hydrogen-Ion Concentration Lactic Acid Laxatives Potassium Pregnancy Prescriptions Sexually Transmitted Diseases / prevention & control Spermatocidal Agents United States

来  源:   DOI:10.1080/17512433.2022.2100347

Abstract:
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要:
非激素处方阴道pH调节剂(VPM)凝胶(Phexxi®),活性成分乳酸,柠檬酸和酒石酸氢钾,最近在美国被批准用于预防怀孕。本综述的目的是收集已发表的临床前和临床试验提供的证据,以支持其使用。
搜索PubMed关于VPM凝胶的公开文献。在clinicaltrials.gov数据库中发现了两项III期试验。结果表明,VPM凝胶是安全的,副作用最小,且有效(累计6-7周期妊娠率为4.1-13.65%,(珍珠指数27.5)作为避孕药。杀微生物效果表明预防性传播感染(STIs)的潜力;目前正在进行III期临床试验,以评估衣原体和淋病的预防。
非激素可逆避孕方法仅限于需要训练有素的临床医生插入的高效铜释放宫内节育器,以及不太有效的联合相关屏障和杀精子剂选择,这些选择通常是非处方药。杀精剂,提高屏障装置的功效,可能会增加艾滋病毒/性传播感染的风险。VPM凝胶提供了一种新的安全,有效的非激素避孕选择,具有预防性传播感染的潜力。
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