Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
NCT ID: NCT02432404
Last Updated: 2025-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2016-03-31
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cyclic NuvaRing CVR Use
CVR use for 3 weeks, remove for 1 week, then replace
NuvaRing
Continuous NuvaRing CVR Use
CVR use for 4 weeks, then replace
NuvaRing
Interventions
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NuvaRing
Eligibility Criteria
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Inclusion Criteria
* BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months
* Willing to use the NuvaRing as directed
* Not intending or wishing to become pregnant over the course of the study
* Capable of providing written informed consent
Exclusion Criteria
* Desire/intent to become pregnant over the course of the study
* Women who are less than 6 weeks postpartum
* Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years
* Current IUD
* Unable to comprehend consent material because of language barrier or psychological difficulty
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of Washington
OTHER
Responsible Party
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Christine Johnston
Assistant Professor, Medicine/Division of Allergy and Infectious Diseases
Principal Investigators
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Christine Johnston, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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UW Virology Research Clinic
Seattle, Washington, United States
Countries
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References
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Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.
Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37.
Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26.
Heffron R, Donnell D, Rees H, Celum C, Mugo N, Were E, de Bruyn G, Nakku-Joloba E, Ngure K, Kiarie J, Coombs RW, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis. 2012 Jan;12(1):19-26. doi: 10.1016/S1473-3099(11)70247-X. Epub 2011 Oct 3.
Vodstrcil LA, Hocking JS, Law M, Walker S, Tabrizi SN, Fairley CK, Bradshaw CS. Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis. PLoS One. 2013 Sep 4;8(9):e73055. doi: 10.1371/journal.pone.0073055. eCollection 2013.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00003584
Identifier Type: -
Identifier Source: org_study_id
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