Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 18 for:    "Vaginitis" | "Fluconazole"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00503542
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : January 8, 2014
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 18, 2007
Last Update Posted Date January 8, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
Self-reported improvement in symptoms [ Time Frame: within 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
Self-reported improvement in symptoms
Change History Complete list of historical versions of study NCT00503542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Adverse reactions to treatment. [ Time Frame: within two weeks ]
  • Incidence of STD's [ Time Frame: at time of presentation ]
  • Vaginal Complaints Scale [ Time Frame: within 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
  • Adverse reactions to treatment.
  • Incidence of STD's
  • Vaginal Complaints Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
Official Title  ICMJE Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
Brief 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.
Detailed Description Setting: The study will be carried out at two sites within the New York City Research and Improvement Network (NYC RING) an urban Practice Based Research Network comprising 21 clinical sites. Problem: Vaginal symptoms are the most common reason for outpatient gynecological consultation, yet the management of these symptoms is not well grounded in evidence from primary care. Purpose: To prepare for a randomized clinical trial (RCT) to test whether the current standard of care for evaluating vaginal symptoms (which involves looking for specific pathogens) produces better clinical outcomes than a simpler approach, which treats patients based on their symptoms. Methods: 55 premenopausal non-pregnant adult women presenting with vaginal complaints will be randomized into two groups. Women in Group A will be managed on the basis of presenting complaint without physical examination or office laboratory work. Women in Group B will receive a physical examination and office evaluation looking for trichomonads, candida and bacterial vaginosis. They will be managed according to the clinical and office laboratory findings. Patients will be contacted by phone two weeks after consultation to assess symptom resolution, adverse reaction to drugs, satisfaction with care and treatment experiences. Patients will be screened for infection with gonorrhea and chlamydia using a urine antigen test and for trichomoniasis using vaginal culture. Patients whose tests demonstrate trichomoniasis, chlamydia or gonorrhea or who remain symptomatic at the two-week follow-up call will be re-evaluated promptly. Outcomes: AIM 1: Feasibility: The pilot will assess 1) ability to recruit and retain patients, 2) acceptability of study protocols to subjects and 3) prevalence and detection of important sexually transmitted diseases (STD's). AIM 2: Initial evidence of effectiveness: The pilot will provide data on key planned RCT outcome measurements including 1) treatment success rates (allowing estimation of future sample size), 2) need for reconsultation 3) adverse reactions, 4) medication usage and 5) patient satisfaction. Benefit to public health: This pilot study will lead to a RCT of the management of vaginal complaints in primary care. This RCT may support current practice, reinforcing the need for physical exam and laboratory testing in all patients. On the other hand, the trial may support a more limited approach that avoids a pelvic examination. This could result in substantial savings of health care dollars with equivalent clinical outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vaginitis
Intervention  ICMJE
  • 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
    Other Names:
    • Flagyl
    • Cleocin
  • Drug: Flagyl for definitively diagnosed vaginal trichomoniasis
    Metronidazole 2 gms po x 1
    Other Name: Flagyl
  • Other: Empiric Management
    In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
    Other Names:
    • Flagyl
    • Metronidazole
    • Fluconazole
    • Diflucan
Study Arms  ICMJE
  • Experimental: Intervention
    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.
    Interventions:
    • Drug: Terazol or oral fluconazole for candidal vaginitis
    • Drug: Metronidazole or Clindamycin for Bacterial Vaginosis
    • Drug: Flagyl for definitively diagnosed vaginal trichomoniasis
    • Other: Empiric Management
  • Active Comparator: Control
    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
    Interventions:
    • Drug: Terazol or oral fluconazole for candidal vaginitis
    • Drug: Metronidazole or Clindamycin for Bacterial Vaginosis
    • Drug: Flagyl for definitively diagnosed vaginal trichomoniasis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2014)
46
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00503542
Other Study ID Numbers  ICMJE 1R03HS016050-01( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew R. Anderson, MD, Montefiore Medical Center
Study Sponsor  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew R. Anderson, MD, MSc Montefiore Medical Center
PRS Account Agency for Healthcare Research and Quality (AHRQ)
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP