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

This study has been completed.
Sponsor:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00503542
First received: July 17, 2007
Last updated: January 7, 2014
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Vaginitis
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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Self-reported improvement in symptoms [ Time Frame: within 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse reactions to treatment. [ Time Frame: within two weeks ] [ Designated as safety issue: Yes ]
  • Incidence of STD's [ Time Frame: at time of presentation ] [ Designated as safety issue: Yes ]
  • Vaginal Complaints Scale [ Time Frame: within 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503542

Locations
United States, New York
Family Health Center
Bronx, New York, United States, 10458
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew R. Anderson, MD, MSc Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Matthew R. Anderson, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00503542     History of Changes
Other Study ID Numbers: 1 R03 HS016050-01
Study First Received: July 17, 2007
Last Updated: January 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Vaginitis
Bacterial Vaginosis
Vaginal trichomoniasis
Vulvovaginal candidiasis

Additional relevant MeSH terms:
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Clindamycin palmitate
Clindamycin phosphate
Metronidazole
Fluconazole
Clindamycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014