Trial Outcomes & Findings for Randomized Controlled Trial of Treatment of Male Partners of Women With BV (NCT NCT02209519)
NCT ID: NCT02209519
Last Updated: 2020-04-27
Results Overview
the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH \> 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score \>3 No Recurrence/Persistence is measured by: \- Presence of 0 -2 Amsel criteria; Nugent score 0-3.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
16 weeks post start of receipt of study drug
Results posted on
2020-04-27
Participant Flow
Participant milestones
| Measure |
Metronidazole
Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
Metronidazole (male partner): 500 mg PO BID for 7 days
|
Placebo
Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
Placebo (male partner): matching placebo capsules PO BID for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
107
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Baseline characteristics by cohort
| Measure |
Metronidazole
n=107 Participants
Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
Metronidazole (male partner): 500 mg PO BID for 7 days
|
Placebo
n=107 Participants
Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
Placebo (male partner): matching placebo capsules PO BID for 7 days
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
african american
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
multiracial
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-hispanic
|
101 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
107 participants
n=7 Participants
|
214 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks post start of receipt of study drugPopulation: those completing the study
the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH \> 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score \>3 No Recurrence/Persistence is measured by: \- Presence of 0 -2 Amsel criteria; Nugent score 0-3.
Outcome measures
| Measure |
Metronidazole
n=107 Participants
Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
Metronidazole (male partner): 500 mg PO BID for 7 days
|
Placebo
n=107 Participants
Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
Placebo (male partner): matching placebo capsules PO BID for 7 days
|
|---|---|---|
|
Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female
|
87 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: from the end of week 1 up to 16 weeksPopulation: unable to collect data due to lab issues
time to recurrence measured in days
Outcome measures
Outcome data not reported
Adverse Events
Metronidazole
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metronidazole
n=107 participants at risk
Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
Metronidazole (male partner): 500 mg PO BID for 7 days
|
Placebo
n=107 participants at risk
Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
Placebo (male partner): matching placebo capsules PO BID for 7 days
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
trauma
|
0.00%
0/107 • baseline through 16 weeks
|
0.93%
1/107 • baseline through 16 weeks
|
Other adverse events
| Measure |
Metronidazole
n=107 participants at risk
Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days
Metronidazole (male partner): 500 mg PO BID for 7 days
|
Placebo
n=107 participants at risk
Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days
Placebo (male partner): matching placebo capsules PO BID for 7 days
|
|---|---|---|
|
Infections and infestations
Infections and infestations
|
16.8%
18/107 • Number of events 18 • baseline through 16 weeks
|
19.6%
21/107 • Number of events 21 • baseline through 16 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/107 • baseline through 16 weeks
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
|
Musculoskeletal and connective tissue disorders
musculoskelatal
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
0.00%
0/107 • baseline through 16 weeks
|
|
Nervous system disorders
nervous
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
2.8%
3/107 • Number of events 3 • baseline through 16 weeks
|
|
Psychiatric disorders
psychiatric
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
0.00%
0/107 • baseline through 16 weeks
|
|
Reproductive system and breast disorders
reproductive system
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
0.00%
0/107 • baseline through 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
|
Skin and subcutaneous tissue disorders
skin
|
0.93%
1/107 • Number of events 1 • baseline through 16 weeks
|
0.00%
0/107 • baseline through 16 weeks
|
|
Gastrointestinal disorders
gastrointestinal
|
4.7%
5/107 • Number of events 5 • baseline through 16 weeks
|
4.7%
5/107 • Number of events 5 • baseline through 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place