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Table 2 In- and exclusion criteria

From: The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy

Inclusion criteria

» Able and willing to give informed consent/assent, according to national guidelines

» Female who self-reports to be sexually active (meaning at least one penetrative vaginal coital act per month for the last 3 months prior to screening)

» Between 18 to 35 years old, inclusive

» Currently in good physical and mental health

» Interested in initiating hormonal contraception

» Able and willing to participate in the study as required by the protocol, this includes willing to undergo HIV testing and use a NuvaRing®

» HIV negative at screening as confirmed by rapid HIV testing

Exclusion criteria

» Currently using a modern contraceptive method other than barrier methods

» Use of a hormonal contraceptive method in the three months prior to the screening visit

» Currently using antimicrobial medication

» Pregnant on urine pregnancy test

» History of cardiovascular disease

» History of hysterectomy or genital tract surgery (including cervical polypectomy, dilatation and curettage, hysteroscopy, or laparoscopy) in the three months prior to the screening visit

» History of complications with hormonal contraception or with contra indications for the use of hormonal contraceptives such as:

o History or known predisposition for venous thrombosis

o History of migraine with focal neurological symptoms

o Diabetes mellitus with vascular involvement

o History of pancreatitis or severe hepatic disease

o Known or suspected hypersensitivity to any of the excipients of NuvaRing®

» History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, incontinence or urge incontinence, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction

» Participating in other clinical studies involving investigational products

» Currently breastfeeding

» Currently a smoker