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Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study.

Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P - J Low Genit Tract Dis (2015)

Bottom Line: No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment.Similar results were found in the modified intent-to-treat population.Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.

View Article: PubMed Central - PubMed

Affiliation: 1Segal Institute for Clinical Research, North Miami, FL; 2TMC Life Research, Inc., Houston, TX; 3Atlanta North Gynecology, P.C., Roswell, GA; 4Downtown Women's Health Care, Denver, CO; 5Prosoft Clinical, Wayne, PA; 6Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA; and 7Department of Obstetrics and Gynecology, Drexel University, Philadelphia, PA.

ABSTRACT

Objective: Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration-approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%.

Materials and methods: This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging study enrolled women with a clinical diagnosis of BV. Patients were assigned to MVG 1.3% once daily for 1, 3, or 5 days or MVG 0.75% once daily for 5 days. The therapeutic cure rate, requiring clinical and bacteriological cure, at the end-of-study visit was determined for the per-protocol population. A Kaplan-Meier analysis was used to estimate median time-to-symptom resolution.

Results: In total, 255 women (mean age = 35 y) were enrolled. The per-protocol population included 189 patients. The therapeutic cure rate was higher in the 1-day (13/43, 30.2%), 3-day (12/48, 25.0%), and 5-day (16/49, 32.7%) MVG 1.3% groups versus the MVG 0.75% group (10/49, 20.4%). Median time-to-resolution of fishy odor was shorter in the 3 MVG 1.3% groups versus the MVG 0.75% group. The 5-day MVG 1.3% group had the lowest rate of symptom return. No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment. Similar results were found in the modified intent-to-treat population.

Conclusions: Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.

No MeSH data available.


Related in: MedlinePlus

Disposition of patients. AE, adverse event; MVG, metronidazole vaginal gel.
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Related In: Results  -  Collection


getmorefigures.php?uid=PMC4376277&req=5

Figure 1: Disposition of patients. AE, adverse event; MVG, metronidazole vaginal gel.

Mentions: A total of 255 patients were randomly assigned to treatment and included in the ITT population from 2 February to 26 April 2010. Overall, 234 patients (92%) completed the study and 21 (8%) discontinued early (see Figure 1). Baseline demographics and patient characteristics were similar across treatment groups (see Table 1).


Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study.

Chavoustie SE, Jacobs M, Reisman HA, Waldbaum AS, Levy SF, Hillier SL, Nyirjesy P - J Low Genit Tract Dis (2015)

Disposition of patients. AE, adverse event; MVG, metronidazole vaginal gel.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4376277&req=5

Figure 1: Disposition of patients. AE, adverse event; MVG, metronidazole vaginal gel.
Mentions: A total of 255 patients were randomly assigned to treatment and included in the ITT population from 2 February to 26 April 2010. Overall, 234 patients (92%) completed the study and 21 (8%) discontinued early (see Figure 1). Baseline demographics and patient characteristics were similar across treatment groups (see Table 1).

Bottom Line: No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment.Similar results were found in the modified intent-to-treat population.Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.

View Article: PubMed Central - PubMed

Affiliation: 1Segal Institute for Clinical Research, North Miami, FL; 2TMC Life Research, Inc., Houston, TX; 3Atlanta North Gynecology, P.C., Roswell, GA; 4Downtown Women's Health Care, Denver, CO; 5Prosoft Clinical, Wayne, PA; 6Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA; and 7Department of Obstetrics and Gynecology, Drexel University, Philadelphia, PA.

ABSTRACT

Objective: Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration-approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%.

Materials and methods: This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging study enrolled women with a clinical diagnosis of BV. Patients were assigned to MVG 1.3% once daily for 1, 3, or 5 days or MVG 0.75% once daily for 5 days. The therapeutic cure rate, requiring clinical and bacteriological cure, at the end-of-study visit was determined for the per-protocol population. A Kaplan-Meier analysis was used to estimate median time-to-symptom resolution.

Results: In total, 255 women (mean age = 35 y) were enrolled. The per-protocol population included 189 patients. The therapeutic cure rate was higher in the 1-day (13/43, 30.2%), 3-day (12/48, 25.0%), and 5-day (16/49, 32.7%) MVG 1.3% groups versus the MVG 0.75% group (10/49, 20.4%). Median time-to-resolution of fishy odor was shorter in the 3 MVG 1.3% groups versus the MVG 0.75% group. The 5-day MVG 1.3% group had the lowest rate of symptom return. No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment. Similar results were found in the modified intent-to-treat population.

Conclusions: Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.

No MeSH data available.


Related in: MedlinePlus