Trial Outcomes & Findings for Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (NCT NCT05399641)
NCT ID: NCT05399641
Last Updated: 2024-07-10
Results Overview
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
14 days post-Baseline - Test-Of-Cure (TOC)
Results posted on
2024-07-10
Participant Flow
Participant milestones
| Measure |
Group A
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
62
|
61
|
|
Overall Study
COMPLETED
|
18
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
9
|
22
|
19
|
Reasons for withdrawal
| Measure |
Group A
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
11
|
7
|
|
Overall Study
Reason not defined
|
3
|
5
|
6
|
Baseline Characteristics
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
Baseline characteristics by cohort
| Measure |
Group A
n=27 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=62 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=61 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 14.80 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 12.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days post-Baseline - Test-Of-Cure (TOC)Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
Percentage of participants with complete resolution of signs and symptoms (total VSS score of 0) with no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Cure
|
7 Participants
|
10 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of TreatmentPopulation: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
Percentage of participants with a Total Composite Score of ≤1 on the VSS Scale and a Total Composite Score of ≤2 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Improvement
VSS Score ≤2, (TOC)
|
11 Participants
|
23 Participants
|
33 Participants
|
|
Clinical Improvement
VSS Score ≤1, (TOC)
|
10 Participants
|
20 Participants
|
29 Participants
|
|
Clinical Improvement
VSS Score ≤1, (14 days post-EOT)
|
3 Participants
|
8 Participants
|
22 Participants
|
|
Clinical Improvement
VSS Score ≤1, (30 days post-Baseline)
|
10 Participants
|
18 Participants
|
24 Participants
|
|
Clinical Improvement
VSS Score ≤1, (30 days post-EOT
|
3 Participants
|
8 Participants
|
20 Participants
|
|
Clinical Improvement
VSS Score ≤1, (60 days post-EOT)
|
8 Participants
|
18 Participants
|
21 Participants
|
|
Clinical Improvement
VSS Score ≤2, (14 days post-EOT)
|
3 Participants
|
10 Participants
|
26 Participants
|
|
Clinical Improvement
VSS Score ≤2, (30 days post-Baseline)
|
10 Participants
|
20 Participants
|
26 Participants
|
|
Clinical Improvement
VSS Score ≤2, (30 days post-EOT)
|
3 Participants
|
8 Participants
|
20 Participants
|
|
Clinical Improvement
VSS Score ≤2, (60 days post-EOT)
|
8 Participants
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at screening
Percentage of participants with at least 50% reduction from baseline in the total composite VSS score and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Success
30 days post-Baseline
|
10 Participants
|
23 Participants
|
27 Participants
|
|
Clinical Success
TOC
|
11 Participants
|
31 Participants
|
39 Participants
|
|
Clinical Success
14 days post-EOT
|
3 Participants
|
12 Participants
|
28 Participants
|
|
Clinical Success
30 days post-EOT
|
3 Participants
|
9 Participants
|
22 Participants
|
|
Clinical Success
60 days post-EOT
|
8 Participants
|
18 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of Treatment.Population: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
Percentage of participants with negative culture growth for candida or participant was asymptomatic and a culture was not done
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Mycological Response
30 days post-EOT
|
3 Participants
|
9 Participants
|
20 Participants
|
|
Mycological Response
TOC
|
9 Participants
|
23 Participants
|
31 Participants
|
|
Mycological Response
14 days post-EOT
|
3 Participants
|
8 Participants
|
21 Participants
|
|
Mycological Response
30 days post-Baseline
|
7 Participants
|
18 Participants
|
25 Participants
|
|
Mycological Response
60 days post-EOT
|
9 Participants
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-End of Treatment and 60 days post-End of TreatmentPopulation: Modified Intent-to-Treat (mITT) - all treated participants who have a positive culture for candida species at Screening
The number (percentage) of participants with Clinical Cure and Mycological Response at TOC and FU Visits
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Cure and Mycological Response
TOC
|
5 Participants
|
7 Participants
|
16 Participants
|
|
Clinical Cure and Mycological Response
14 days post-EOT
|
3 Participants
|
5 Participants
|
13 Participants
|
|
Clinical Cure and Mycological Response
30 days post-Baseline
|
7 Participants
|
15 Participants
|
20 Participants
|
|
Clinical Cure and Mycological Response
30 days post-EOT
|
3 Participants
|
8 Participants
|
17 Participants
|
|
Clinical Cure and Mycological Response
60 days post-EOT
|
8 Participants
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 14 days post EOT, 30 days post-Baseline, 30 days post-EOT and 60 days post-EOTPopulation: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
The number (percentage) of participants with a total composite score of 0 on the VSS scale and no additional antifungal therapy required. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Cure at Follow-up
30 days post-EOT
|
3 Participants
|
8 Participants
|
17 Participants
|
|
Clinical Cure at Follow-up
14 days post-EOT
|
3 Participants
|
6 Participants
|
17 Participants
|
|
Clinical Cure at Follow-up
30 days post-Baseline
|
7 Participants
|
16 Participants
|
21 Participants
|
|
Clinical Cure at Follow-up
60 days post-EOT
|
8 Participants
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 14 days post-Baseline (TOC), 14 days post-End of Treatment (EOT), 30 days post-Baseline, 30 days post-EOT and 60 days post-EOTPopulation: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
The mean change in total composite vulvovaginal signs and symptom (VSS) score from Baseline to TOC and Follow-up Visits. The VSS score ranges from 0 (no signs and symptoms) to a maximum of 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
TOC
|
-7.2 Score on a scale
Interval -15.0 to 0.0
|
-6.3 Score on a scale
Interval -13.0 to 4.0
|
-8.1 Score on a scale
Interval -16.0 to 2.0
|
|
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
14 days post-EOT
|
-10.0 Score on a scale
Interval -11.0 to -8.0
|
-6.7 Score on a scale
Interval -14.0 to 2.0
|
-7.8 Score on a scale
Interval -16.0 to 4.0
|
|
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
30 days post-Baseline
|
-7.0 Score on a scale
Interval -17.0 to 9.0
|
-7.1 Score on a scale
Interval -13.0 to 3.0
|
-8.3 Score on a scale
Interval -17.0 to 5.0
|
|
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
30 days post-EOT
|
-10.7 Score on a scale
Interval -11.0 to -10.0
|
-7.6 Score on a scale
Interval -13.0 to 0.0
|
-8.0 Score on a scale
Interval -16.0 to 9.0
|
|
Change in Total Composite Vulvovaginal Signs and Symptom Score From Baseline
60 days post-EOT
|
-8.3 Score on a scale
Interval -17.0 to -3.0
|
-8.2 Score on a scale
Interval -16.0 to 2.0
|
-8.5 Score on a scale
Interval -16.0 to 2.0
|
SECONDARY outcome
Timeframe: 14 days post-Baseline Test-Of- Cure (TOC), 14 days post-End of Treatment, 30 days post-Baseline, 30 days post-End of Treatment and 60 days post- End of TreatmentPopulation: Modified Intent-to-Treat (mITT): all treated participants who have a positive culture for candida species at Screening
Percentage of subjects with a Total Composite Score of 2 on the VSS Scale or a composite score of 1 on the VSS scale. The vulvovaginal signs and symptom (VSS) scale ranges from 0 to 18, with higher scores being worse.
Outcome measures
| Measure |
Group A
n=13 Participants
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=42 Participants
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=46 Participants
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Clinical Improvement - 2
VSS Score of 1 at TOC
|
3 Participants
|
10 Participants
|
6 Participants
|
|
Clinical Improvement - 2
VSS Score of 1 at 14 days post-EOT
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Clinical Improvement - 2
VSS Score of 2 at 30 days post-EOT
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Improvement - 2
VSS Score of 1 at 30 days post-Baseline
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Clinical Improvement - 2
VSS Score of 1 at 30 days post-EOT
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Clinical Improvement - 2
VSS Score of 1 at 60 days post-EOT
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Improvement - 2
VSS Score of 2 at TOC
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Clinical Improvement - 2
VSS Score of 2 at 14 days post-EOT
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Clinical Improvement - 2
VSS Score of 2 at 30 days post-Baseline
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Clinical Improvement - 2
VSS Score of 2 at 60 days post-EOT
|
0 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group B (3 Day Dosing)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Group B (7 Day Dosing)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=27 participants at risk
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (3 Day Dosing)
n=62 participants at risk
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
Group B (7 Day Dosing)
n=61 participants at risk
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Ibrexafungerp: Each day dosing will consist of two 150mg tablets taken BID.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
6/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
29.0%
18/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
32.8%
20/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
3/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
25.8%
16/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
11.5%
7/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
4.8%
3/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
6.6%
4/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
1.6%
1/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
8.2%
5/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
|
Gastrointestinal disorders
Bacterial vaginosis
|
11.1%
3/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
1.6%
1/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
8.2%
5/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
|
Gastrointestinal disorders
Headache
|
3.7%
1/27 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
8.1%
5/62 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
9.8%
6/61 • From participant Screening through to 60 post-End of Therapy Visit (approximately 69 days after Screening)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place