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Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network

NCT00503542 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-01-08

No results posted yet for this study

Summary

Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.

Conditions

  • Vaginitis

Interventions

DRUG

Terazol or oral fluconazole for candidal vaginitis

Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1

DRUG

Metronidazole or Clindamycin for Bacterial Vaginosis

Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin

DRUG

Flagyl for definitively diagnosed vaginal trichomoniasis

Metronidazole 2 gms po x 1

OTHER

Empiric Management

In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    lead FED

Principal Investigators

  • Matthew R. Anderson, MD, MSc · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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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 NCT00503542 on ClinicalTrials.gov