Single Dose Oral Treatment for Vaginal Trichomoniasis and Bacterial Vaginosis. A Comparison of Nitazoxanide and Metronidazole

Not Applicable

Completed

• Conditions: N760; -N760 Acute vaginitis-A590 Urogenital trichomoniasis; Urogenital trichomoniasis; Acute vaginitis; A590

• Registration Number: PER-031-05
• Lead Sponsor: GRUPO FARMAKONSUMA S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-03
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Women aged 18 to 48 years who give their consent in writing and with a diagnosis of vaginal trichomoniasis, bacterial vaginosis or both, proven by clinical findings, defined by the researcher, fresh smear of positive vaginal secretion and 3 or more criteria of Amsel positive, respectively.

Exclusion Criteria

1) Patients under 18 years and over 48 years of age.
2) Patients with suspected concomitant diagnosis of mycosis
vaginal or other pathology not considered in the inclusion criteria.
3) Patients in which a breach is foreseen in the
follow up of the study.
4) Patients who do not sign informed consent.
5) Patients with concomitant diseases that, in the opinion of the researcher, discourage their inclusion in the study.
6) Patients with known hypersensitivity to imidazoles.
7) Patients with suspected blood dyscrasias.
8) Patients with suspicion or history of deterioration of the
liver or kidney function.
9) Patients with suspected pregnancy or breast-feeding.
10) Patients with suspected acute or chronic disease of the
SNC.
11) Patients whose pathological situation may interfere with the
development of the study.
12) Patients who use concomitant coumarins and / or
warfarin.
13) Patients with NSAID use up to seven days before the
administration of the treatment.
14) Patients who are consuming at the time of the study
some antiparasitic medication, antibiotic or whatever
Consumed up to 15 days before its inclusion.
15) Patients with suspected digestive pathology (gastritis,
hepatitis, ulcer, etc.).
16) Patients with more than one sexual partner reported.
17) Patients with BMI less than 18.85 and greater than 26.9.

Study & Design

• Study Type: Interventional
• Study Design: Not specified