Trial Outcomes & Findings for Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study (NCT NCT00464542)
NCT ID: NCT00464542
Last Updated: 2017-05-11
Results Overview
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
COMPLETED
PHASE4
12 participants
30 days after cessation of metronidazole therapy
2017-05-11
Participant Flow
Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. Two of these women were lost to follow-up within 2 weeks of enrollment. A third woman was lost to follow-up after initiating metronidazole therapy at study midpoint.
Participant milestones
| Measure |
MASH Cohort
This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
|
|---|---|
|
Pre-treatment
STARTED
|
12
|
|
Pre-treatment
COMPLETED
|
10
|
|
Pre-treatment
NOT COMPLETED
|
2
|
|
Post-treatment
STARTED
|
10
|
|
Post-treatment
COMPLETED
|
10
|
|
Post-treatment
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
MASH Cohort
This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
|
|---|---|
|
Pre-treatment
Withdrawal by Subject
|
2
|
Baseline Characteristics
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Baseline characteristics by cohort
| Measure |
MASH Cohort
n=12 Participants
This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after cessation of metronidazole therapyPopulation: per protocol
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
Outcome measures
| Measure |
Post-treatment MASH Cohort
n=9 Participants
Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
|
|---|---|
|
Number of Participants With Bacterial Vaginosis Recurrence
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 days after cessation of metronidazole therapyThe time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy
Outcome measures
| Measure |
Post-treatment MASH Cohort
n=9 Participants
Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
|
|---|---|
|
Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
|
14 Days
Interval 7.0 to 24.0
|
Adverse Events
MASH Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place