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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | 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 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
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:
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:
|
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:
Drug: Flagyl for definitively diagnosed vaginal trichomoniasis
Metronidazole 2 gms po x 1
Other Name: Flagyl
|
- Self-reported improvement in symptoms [ Time Frame: within 2 weeks ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 52 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503542
United States, New York | |
Family Health Center | |
Bronx, New York, United States, 10458 |
Principal Investigator: | Matthew R. Anderson, MD, MSc | Montefiore Medical Center |
Responsible Party: | Matthew R. Anderson, MD, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00503542 History of Changes |
Other Study ID Numbers: |
1R03HS016050-01 ( U.S. AHRQ Grant/Contract ) |
First Posted: | July 18, 2007 Key Record Dates |
Last Update Posted: | January 8, 2014 |
Last Verified: | September 2007 |
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 |