Trial Outcomes & Findings for Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial (NCT NCT00545181)

NCT ID: NCT00545181

Last Updated: 2010-01-12

Results Overview

Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH \>4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2010-01-12

Participant Flow

Participant milestones

Measure	Metronidazole + Acidifying Gel (RepHresh) Receive metronidazole plus vaginal acidifying gel	Metronidazole Alone Metronidazole antibiotic therapy alone
Overall Study STARTED	29	25
Overall Study COMPLETED	29	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Baseline characteristics by cohort

Measure	Metronidazole + Acidifying Gel (RepHresh) n=29 Participants Receive metronidazole plus vaginal acidifying gel	Metronidazole Alone n=25 Participants Metronidazole antibiotic therapy alone	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29.8 years STANDARD_DEVIATION 5.8 • n=5 Participants	32.4 years STANDARD_DEVIATION 6.9 • n=7 Participants	31.0 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	25 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.

Outcome measures

Measure	Metronidazole + Acidifying Gel (RepHresh) n=29 Participants Receive metronidazole plus vaginal acidifying gel	Metronidazole Alone n=25 Participants Metronidazole antibiotic therapy alone
Recurrent Bacterial Vaginosis	7 Participants	7 Participants

Adverse Events

Metronidazole + Acidifying Gel (RepHresh)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metronidazole Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Haas, MD MS

Indiana University School of Medicine

Phone: 3176307837

Email: dahaas@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place