CLINICAL TRIALS PROFILE FOR METROGEL-VAGINAL
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All Clinical Trials for METROGEL-VAGINAL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01020396 ↗ | Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis | Completed | Teva Pharmaceuticals USA | Phase 1/Phase 2 | 2002-01-01 | The purpose of this study was to demonstrate comparable efficacy, safety, and tolerability of Teva Pharmaceuticals USA's generic formulation of Metronidazole Vaginal Gel, 0.75% and 3M Pharmaceuticals' MetroGel-Vaginal® metronidazole vaginal gel, 0.75% to establish clinical equivalence in the treatment of bacterial vaginosis. |
| NCT01020877 ↗ | Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects | Completed | Teva Pharmaceuticals USA | Phase 1 | 2001-11-01 | The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects. |
| NCT02376972 ↗ | Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis | Terminated | Parexel | Phase 2 | 2015-04-01 | THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS |
| NCT02376972 ↗ | Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis | Terminated | Alfa Wassermann S.p.A. | Phase 2 | 2015-04-01 | THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS |
| NCT02376972 ↗ | Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis | Terminated | Alfasigma S.p.A. | Phase 2 | 2015-04-01 | THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS |
| NCT02766023 ↗ | LACTIN-V Study for Recurrent Bacterial Vaginosis | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2016-06-03 | This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo. |
| NCT04478617 ↗ | PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial? | Recruiting | New York Medical College | Phase 4 | 2020-07-15 | Despite use of intravenous antibiotic prophylaxis, pelvic infection including vaginal and urinary complaints and infections are still noted after hysterectomy. For gynecologic surgery the burden of infection is not only from the skin but from the vagina and urinary tract. Hysterectomy involves a communication via the cervical or vaginal canal directly with the pelvis and thus can lead to a potentially increased risk of infection from both aerobic and anaerobic organisms. Vaginal metronidazole is a standard of care antibiotic for vaginal infections including bacterial vaginosis. Based upon small studies in the peri-operative setting, vaginal metronidazole may provide a benefit in decreasing surgical site infections and urinary infections in conjunction with standard infection prevention protocols. This study is for women undergoing elective subtotal or total hysterectomy by any route of surgery. The main objective of this study is to evaluate if metronidazole inserted per vagina daily for 5 days before elective hysterectomy decreases patient complaints of potential infection or documented post-operative infection. Subjects will be randomized to an intervention or control group. For subjects in the intervention group, vaginal metronidazole 0.75% (MetroGel or Vandazole) will be prescribed and inserted per vagina days 1 through 5 prior to date of surgery. The control group will not receive a metronidazole prescription. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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