Status:
COMPLETED
Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Rinda Ubuzima
University of Liverpool
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is a multidisciplinary research project and has two main aims: 1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis on its effect on the vaginal micro...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01796613
Start Date
June 1 2013
End Date
March 1 2014
Last Update
March 11 2015
Active Locations (1)
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1
Rinda Ubuzima
Kigali, Rwanda