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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02445989 |
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Date of registration:
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20/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
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Scientific title:
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Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02445989 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Jeanne M Marrazzo, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BV+ by Amsel Criteria
- Not intending to become pregnant over the course of the study
- If HIV infected, not taking ART
- Capable of providing written informed consent
Exclusion Criteria:
- Current pregnancy
- Desire/intent to become pregnant over the course of the study
- Contraindications to hormonal contraceptive use
- Current cigarette smoking if age is older than 35 years
- Unable to comprehend consent material because of language barrier or psychological
difficulty
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV
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Bacterial Vaginosis
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Intervention(s)
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Drug: NuvaRing
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Primary Outcome(s)
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Quantity of L. crispatus determined by species-specific qPCR assay
[Time Frame: Up to 8 months]
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Secondary Outcome(s)
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Number of adverse events with CVR use
[Time Frame: Up to 8 months]
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Acceptability of CVR to male sex partners of study participants assessed by questionnaire
[Time Frame: Up to 1 month]
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Rates of bacterial vaginosis during contraceptive ring uses
[Time Frame: Up to 8 months]
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Secondary ID(s)
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48663
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R01HD077872
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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