Efficacy, safety and user-friendliness of a novel sustained-release oligomeric lactic acid pessary in the treatment of patients with confirmed bacterial vaginosis: a randomized multicenter open-label parallel-group two-part study

accure AB (Sweden)0 个研究点目标入组 128 人开始时间: 2014年3月21日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Females at least 18 years of age
•2. Confirmed current diagnosis of bacterial vaginosis (determined at study screening) using Amsel's criteria
•3. Subjects who are willing to refrain from the use of all other vaginal products throughout the study except for intrauterine device
•4. Subjects must abstain from sexual intercourse or use condoms throughout the duration of the study
•5. Women of child-bearing potential must have a negative urine pregnancy test result upon entry into the study
•6. Subject is willing to answer questions mainly related to product acceptability but some that are related to sexual activity
•7. Subjects who are able to give written informed consent and agree to follow-up on time

•1. Women planning to become pregnant during the study period
•2. Menstruating at the time of the diagnosis or anticipate the onset of menses during the course of the study
•3. Post-menopausal women (definition: a woman experiencing 12 consecutive months of amenorrhea)
•4. Received vaginal or oral antibiotics or pH restoring product(s) within two weeks prior to study enrolment
•5. Subjects with yeast or trichomonas infection, diagnosed by microscopy
•6. Suspicion of low genital tract infection, e.g. chlamydia or gonococcus infection
•7. Subject with signs of vulvovaginal irriation where concomitant vaginal disease is suspected
•8. Subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
•9. Subjects previously participated in this study

发起方

accure AB (Sweden)