Trial Outcomes & Findings for Multi-Center Study of New Medications to Treat Vaginal Infections (NCT NCT02308033)
NCT ID: NCT02308033
Last Updated: 2020-07-27
Results Overview
The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
7-14 days after beginning treatment
Results posted on
2020-07-27
Participant Flow
Participant milestones
| Measure |
Metronidazole Vaginal Gel
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
76
|
83
|
|
Overall Study
NOT COMPLETED
|
26
|
19
|
Reasons for withdrawal
| Measure |
Metronidazole Vaginal Gel
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Overall Study
Normal Gram stain at Baseline
|
13
|
10
|
|
Overall Study
Positive for STD at Baseline
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
Baseline Characteristics
Multi-Center Study of New Medications to Treat Vaginal Infections
Baseline characteristics by cohort
| Measure |
Metronidazole Vaginal Gel
n=76 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=83 Participants
One applicator full at bedtime
Gel vehicle
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
83 participants
n=7 Participants
|
159 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-14 days after beginning treatmentPopulation: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells
Outcome measures
| Measure |
Metronidazole Vaginal Gel
n=76 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=83 Participants
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
|
47 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after beginning treatmentPopulation: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%).
Outcome measures
| Measure |
Metronidazole Vaginal Gel
n=76 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=83 Participants
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Improvement of BV Clue Cells
Clue cells absent
|
52 Participants
|
19 Participants
|
|
Improvement of BV Clue Cells
Clue cells present
|
17 Participants
|
58 Participants
|
|
Improvement of BV Clue Cells
Data missing
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after beginning treatmentPopulation: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
Outcome measures
| Measure |
Metronidazole Vaginal Gel
n=76 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=83 Participants
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Microbiologic Improvement/Cure
Normal Nugent score
|
38 Participants
|
7 Participants
|
|
Microbiologic Improvement/Cure
Intermediate Nugent score
|
16 Participants
|
11 Participants
|
|
Microbiologic Improvement/Cure
BV Nugent score
|
15 Participants
|
59 Participants
|
|
Microbiologic Improvement/Cure
Not taken
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7-14 days after beginning treatmentPopulation: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Outcome measures
| Measure |
Metronidazole Vaginal Gel
n=76 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=83 Participants
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
|
43 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Any time during study participation (up to 30 days)Population: The safety population includes all subjects randomized to treatment and administered at least one dose of study drug.
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Outcome measures
| Measure |
Metronidazole Vaginal Gel
n=96 Participants
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=97 Participants
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
42 Participants
|
31 Participants
|
Adverse Events
Metronidazole Vaginal Gel
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Gel Vehicle
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metronidazole Vaginal Gel
n=96 participants at risk
One applicator full at bedtime
Metronidazole
|
Gel Vehicle
n=97 participants at risk
One applicator full at bedtime
Gel vehicle
|
|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
8.3%
8/96 • Number of events 8 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
6.2%
6/97 • Number of events 6 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.3%
7/96 • Number of events 7 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.2%
5/96 • Number of events 5 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
1.0%
1/97 • Number of events 1 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
|
Nervous system disorders
Headache
|
5.2%
5/96 • Number of events 5 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
2.1%
2/97 • Number of events 2 • Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).
Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting. The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a normal gram stain Nugent score at the baseline visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators have the right to disclose and publish results of the Study conducted by them; provided that, in order to protect any Sponsor confidential information, Investigator shall submit to Sponsor manuscripts at least 30 days before submission for publication or 10 days before public presentation. After that time, Investigator is free to submit the manuscript for publication or deliver the presentation, provided Investigator removes any confidential information as directed by Sponsor
- Publication restrictions are in place
Restriction type: OTHER