Clinical Trials Logo
  1. Home
  2. Vaginosis, Bacterial
  3. NCT01055106

Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

Vaginal Infection Clinical Trial

Official title:
A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.

Clinical Trial Description

This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total study duration may be up to 30 days for a subject.

Study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators.

Investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site.

Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal infection typically does not cause irritation. The most common complaint of patients who suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or may not be increased above a normal discharge. The bad odor may get worse after sexual intercourse or during the menstrual period. BV is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. Therefore, it is important to treat the infection. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01055106
Study type Interventional
Source Graceway Pharmaceuticals, LLC
Contact
Status Completed
Phase Phase 2
Start date January 2010
Completion date April 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT00324246 - Feasibility Study of the NEW NORMA-SENSE Phase 3
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Not yet recruiting NCT05997160 - Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
Recruiting NCT05557318 - Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge N/A
Completed NCT05044156 - Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Completed NCT00694928 - Vaginal Infection Study 2 Phase 3
Not yet recruiting NCT05590195 - Effect of PreforPro® on Urinary and Vaginal Health Phase 3
Completed NCT03898726 - Laparoscopic Versus Transvaginal Cuff Closure N/A
Withdrawn NCT01542606 - Performance Proof of Product Developed to Detect Abnormal Vaginal pH N/A
Not yet recruiting NCT05806879 - Impact of Maternity Napkins on the Incidence of Vaginal Infections in the Post-partum Period N/A
Completed NCT02308033 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT02308046 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT02308007 - Multi-Center Study of New Medications to Treat Vaginal Infections Phase 3
Completed NCT01599416 - Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative N/A
Recruiting NCT04719754 - Epidemiology of Abnormal Vaginal Discharge During Pregnancy
Completed NCT03008421 - Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy N/A
Completed NCT03261804 - Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users
Terminated NCT05788991 - Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis Phase 4
Completed NCT01843166 - Vaginal Estrogen With Pessary Treatment N/A
Not yet recruiting NCT03532464 - Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection Phase 4