Vaginitis Clinical Trial
— VCATOfficial title:
Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 52 Years |
Eligibility |
Inclusion Criteria: - Eligible patients will be premenopausal, non-pregnant women presenting with a chief complaint of vaginal itch, malodor, discharge, pain, irritation or rash. We will accept patient history of being pre-menopausal as valid. Exclusion Criteria: - We will exclude women over 45 who have undergone hysterectomy. We will exclude patients who cannot be reached by phone for follow-up interviews. We will exclude pregnant women because of concerns that the diagnosis and treatment of bacterial vaginosis plays a role in pre-term labor prevention. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Family Health Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported improvement in symptoms | within 2 weeks | No | |
Secondary | Adverse reactions to treatment. | within two weeks | Yes | |
Secondary | Incidence of STD's | at time of presentation | Yes | |
Secondary | Vaginal Complaints Scale | within 2 weeks | No |
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