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

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:

MedlinePlus related topics: Trichomoniasis Vaginal Diseases

Drug Information available for: Metronidazole Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Terconazole Metronidazole hydrochloride Fluconazole

U.S. FDA Resources

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

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 (Adult)
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

Agency for Healthcare Research and Quality (AHRQ)

Investigators


Principal Investigator:	Matthew R. Anderson, MD, MSc	Montefiore Medical Center

More Information


Responsible Party:	Matthew R. Anderson, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00503542 History of Changes
Other Study ID Numbers:	1R03HS016050-01
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 Terconazole Metronidazole Clindamycin Fluconazole Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents	Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

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