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Study of Nuvaring Acceptability, Adherence and Biological Effects Among HIV-negative Women in Kenya

NCT02529683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-08-20

No results posted yet for this study

Summary

One arm clinical trial of Nuvaring use for six months among 200 previously contracepting HIV-negative women (COCPs or DMPA) aged 18-35 in Kenya, where no vaginal rings are licensed/available for contraception or other indications. This was meant to be a formative research study to understand the predictors of acceptability and adherence to a contraceptive vaginal ring, and its immunoogical and microbiological effects over six months of product use.

Conditions

  • Hormonal Contraception

Interventions

DRUG

Nuvaring

contraceptive vaginal ring with ethinyl estradiol and etonogestrel

Sponsors & Collaborators

Principal Investigators

  • Mumbi Makanga, MBChB · Kenya Medical Research Institute

  • Beatrice Nyagol, MN · Kenya Medical Research Institute

  • Eleanor McLellan-Lemal, PhD · US CDC

  • Mitesh Desai, MD, MPH · US CDC

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

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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 NCT02529683 on ClinicalTrials.gov