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

NCT00503542 | Completed Early Phase 1

• 1 other identifier: 1R03HS016050-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginitis

Keywords

Vaginitis; Bacterial Vaginosis; Vaginal trichomoniasis; Vulvovaginal candidiasis

Outcome Measures

Primary Outcomes (1)

• Self-reported improvement in symptoms

  within 2 weeks

Secondary Outcomes (3)

• Adverse reactions to treatment.

  within two weeks

• Incidence of STD's

  at time of presentation

• Vaginal Complaints Scale

  within 2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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; Drug: Metronidazole or Clindamycin for Bacterial Vaginosis; Drug: Flagyl for definitively diagnosed vaginal trichomoniasis; Other: Empiric Management

Control

ACTIVE COMPARATOR

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; Drug: Metronidazole or Clindamycin for Bacterial Vaginosis; Drug: Flagyl for definitively diagnosed vaginal trichomoniasis

Interventions

Terazol or oral fluconazole for candidal vaginitis DRUG

Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1

Control; Intervention

Metronidazole or Clindamycin for Bacterial Vaginosis DRUG

Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin

Also known as: Flagyl, Cleocin

Control; Intervention

Flagyl for definitively diagnosed vaginal trichomoniasis DRUG

Metronidazole 2 gms po x 1

Also known as: Flagyl

Control; Intervention

Empiric Management OTHER

In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.

Also known as: Flagyl, Metronidazole, Fluconazole, Diflucan

Intervention

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): lead

Study Sites (1)

Family Health Center

The Bronx, New York, 10458, United States

Location

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Trichomonas Vaginitis; Candidiasis, Vulvovaginal

Interventions

terconazole; Fluconazole; Metronidazole; Clindamycin

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Study Officials

• Matthew R. Anderson, MD, MSc

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 8, 2014

Record last verified: 2007-09

Locations

US (1)