Table 2.
In- and exclusion criteria
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 |