Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy

Launched by INSTITUTE OF TROPICAL MEDICINE, BELGIUM · Feb 19, 2013

Keywords

ClinConnect Summary

1. An integrated study design

This clinical study combines a clinical safety evaluation of the contraceptive vaginal ring (CVR) with social science research on acceptability and adherence of ring use in Rwandan women.

The clinical part of the study assesses the general safety of the contraceptive ring including the effect on the vaginal microbiome, genitourinary symptoms and signs and clinical adverse events. In addition the clinical part of the study aims to understand better the possible biofilm formation and to explore the impact of the ring on the microbiome and inflammation in ...

Gender

FEMALE

Eligibility 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:
• • History or known predisposition for venous thrombosis
• • History of migraine with focal neurological symptoms
• • Diabetes mellitus with vascular involvement
• • History of pancreatitis or severe hepatic disease
• • 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