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HIGH DOSE OF INTRAVAGINAL METRONIDAZOLE: EFFECTS IN THE PREVENTION OF RECURRENT BACTERIAL VAGINOSIS

HIGH DOSE OF INTRAVAGINAL METRONIDAZOLE: EFFECTS IN THE PREVENTION OF RECURRENT BACTERIAL VAGINOSIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-083-07
Enrollment
255
Registered
2007-11-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
Five nights of intravaginal suppositories of 37.5 mg of metronidazole. Group name:Group 3 Type of group
Five nights of Intravaginal suppositories of 750 mg of metronidazole plus 200 mg of Miconazole Nitrate

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Women between 18-40 years of age. • Abnormal vaginal discharge or bad-odor. • Quick positive test (QuickVue Advance). • Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: • Women who report diabetes or immunosuppression. • Women who report symptoms of pregnancy, including loss of menstruation for a period greater than 7 days, or positive pregnancy test. • Women who have had a birth in the last 90 days. • Women who have had an abortion during the past 30 days. • Women who are menstruating or breastfeeding. • Oral or intravaginal medications for vaginal discharge during the last 2 weeks. • Inability to attend the follow-up visit one month after treatment ends. • Women with mucopurulent cervical discharge or vaginal bleeding. • Women with signs of pelvic inflammatory disease (eg, painful attachments or pain to cervical mobilization). • Women with ovarian and uterine masses on physical examination. • Women with severe abdominal pain. • Women who are taking cimetidine, phenytoin or coumadin.

Design outcomes

Primary

MeasureTime frame
Outcome name:To compare the persistence rates of VB non-pregnant women between 18-40 years of age, randomly assigned to three different treatment schedules with intravaginal metronidazoi for five nights Measure:Persistence rates Timepoints:28 days

Secondary

MeasureTime frame
Outcome name:To compare the acceptability, adverse effects and adherence to treatment among these three treatment schemes. Measure:Acceptability, adverse effects and adherence to treatment Timepoints:During the treatment

Contacts

Public ContactArmando Cotrina

UNIVERSIDAD PERUANA CAYETANO HEREDIA

acotrina@u.washington.edu

Outcome results

None listed

Source: REPEC (via WHO ICTRP)