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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