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

NCT01796613 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-03-11

No results posted yet for this study

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 microenvironment after different durations of use: the vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and immune activation in the vagina
2. To investigate the feasibility, acceptability and adherence to vaginal ring use in Rwandan women, including attitudes towards a future multi-purpose vaginal ring for prevention of both pregnancy and sexually transmitted infections (STI).

Conditions

  • Contraception

Interventions

DEVICE

Vaginal Ring - intermittent regimen

NuvaRing® used intermittently. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck \& Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.

DEVICE

Vaginal Ring - continuous regimen

NuvaRing® used continuously. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck \& Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.

Sponsors & Collaborators

  • Rinda Ubuzima

    collaborator UNKNOWN

  • University of Liverpool

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Tania Crucitti, PhD · Institute of Tropical Medicine, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Rwanda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796613 on ClinicalTrials.gov