NCT00503542|CompletedEarly Phase 1
Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
VCAT
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VCAT
Sponsor study identifier
AHRQ
interventional
46
1 country
1
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2007
Actual (reported)July 18, 2007
Actual (reported)February 2008
Actual (reported)February 2008
Actual (reported)Self-reported improvement in symptoms
within 2 weeks
Adverse reactions to treatment.
within two weeks
Incidence of STD's
at time of presentation
Vaginal Complaints Scale
within 2 weeks
Patients primarily with itching or irritation are treated for candidal vaginitis. Patients primarily with vaginal odor are treated for bacterial vaginosis. Patients who did not fit either of the previous groups are treated for both candidal vaginitis and bacterial vaginosis.
Patient are examined and a wet mount is prepared. If a definitive diagnosis is made patient is treated for the condition diagnosed. If no diagnosis is made the clinician has the option of either foregoing treatment (watchful waiting) or following the protocol in the experimental group
Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1
Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Metronidazole or Clindamycin for Bacterial Vaginosis
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFamily Health Center
The Bronx, New York, 10458, United States
Matthew R. Anderson, MD, MSc
Montefiore Medical Center
46 participants (actual enrollment reported by the registry).
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Once Daily In-situ Forming Versus Twice-daily Conventional Metronidazole Vaginal Gels for Treatment of Bacterial Vaginosis
Metronidazole 2 gms po x 1
In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
January 8, 2014
Record last verified: 2007-09
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Source: ClinicalTrials.gov.
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