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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: |
NCT02905890 |
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Date of registration:
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09/09/2016 |
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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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The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis
HCBV |
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Scientific title:
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Hormonal Contraception and Bacterial Vaginosis (HCBV): The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Among Women at High Risk for HIV Infection in Kampala, Uganda |
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Date of first enrolment:
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October 2, 2017 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02905890 |
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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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Uganda
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Contacts
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Name:
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Suzanna C Francis, MSc MPH PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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London School of Hygiene and Tropical Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BV positive by Nugent score
- HIV negative
- Capable of providing written informed consent
Exclusion Criteria:
- Currently pregnant or using a reliable contraception (e.g. injectables, intrauterine
devices, implant, oral contraceptive pills)
- Desiring pregnancy in the next year
- History of tubal ligation or hysterectomy
- Contraindication to progestin-only contraceptives
- Unable to comprehend consent material because of language barrier or psychological
difficulty
Age minimum:
18 Years
Age maximum:
35 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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Device: Condoms
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Drug: Norethisterone enantate
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Primary Outcome(s)
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Time to diagnosis of recurrent BV
[Time Frame: 6 months]
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Secondary Outcome(s)
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Acceptability of norethisterone enanthate as measured by qualitative interviews
[Time Frame: 6 months]
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Concentration of markers for inflammation
[Time Frame: 6 months]
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Proportional of participants with Lactobacillus-dominant cluster
[Time Frame: 6 months]
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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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