Trial Outcomes & Findings for Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis (NCT NCT03091777)
NCT ID: NCT03091777
Last Updated: 2020-01-07
Results Overview
Resolution of clinical signs and symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
871 participants
Primary outcome timeframe
Day 21-30
Results posted on
2020-01-07
Participant Flow
Recruitment Period: March 2017 to November 2017 The location of clinical sites included women's health clinics and clinical research centers
All subjects who met the entry criteria were randomized and enrolled into the study.
Participant milestones
| Measure |
Test Drug
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
|---|---|---|---|
|
Overall Study
STARTED
|
289
|
288
|
294
|
|
Overall Study
COMPLETED
|
257
|
255
|
257
|
|
Overall Study
NOT COMPLETED
|
32
|
33
|
37
|
Reasons for withdrawal
| Measure |
Test Drug
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
6
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
12
|
14
|
7
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
5
|
|
Overall Study
Noncompliance with study drug
|
2
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Abnormal Laboratory Value
|
7
|
11
|
12
|
Baseline Characteristics
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
Test Drug
n=287 Participants
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
n=285 Participants
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
n=292 Participants
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
Total
n=864 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 9.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
864 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
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
233 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
701 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 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
|
161 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
483 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
287 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
864 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 21-30Population: Modified Intent-to-Treat (mITT) population: All randomized subjects who received study treatment and returned for at least one post-baseline visit, but excluding those who demonstrate a positive test result for other concomitant vaginal or cervical infections at baseline (e.g. C. trachomatis, N. gonorrhoeae) or who have a baseline Nugent score\<4.
Resolution of clinical signs and symptoms
Outcome measures
| Measure |
Test Drug
n=245 Participants
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
n=245 Participants
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
n=243 Participants
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
|---|---|---|---|
|
Clinical Cure
|
135 Participants
|
129 Participants
|
74 Participants
|
Adverse Events
Test Drug
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Reference Drug
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Vehicle Placebo Gel
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Drug
n=287 participants at risk
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
n=285 participants at risk
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
n=292 participants at risk
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
|---|---|---|---|
|
Gastrointestinal disorders
Intussusception
|
0.35%
1/287 • Number of events 1 • 21 months
|
0.00%
0/285 • 21 months
|
0.00%
0/292 • 21 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.35%
1/287 • Number of events 1 • 21 months
|
0.00%
0/285 • 21 months
|
0.00%
0/292 • 21 months
|
|
Congenital, familial and genetic disorders
Sickle Cell Anaemia
|
0.00%
0/287 • 21 months
|
0.00%
0/285 • 21 months
|
0.34%
1/292 • Number of events 1 • 21 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/287 • 21 months
|
0.00%
0/285 • 21 months
|
0.34%
1/292 • Number of events 1 • 21 months
|
Other adverse events
| Measure |
Test Drug
n=287 participants at risk
GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel.
|
Reference Drug
n=285 participants at risk
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
|
Vehicle Placebo Gel
n=292 participants at risk
GDC-229 Vehicle
Placebo: Inactive arm of the study
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
5/287 • Number of events 5 • 21 months
|
0.35%
1/285 • Number of events 1 • 21 months
|
1.0%
3/292 • Number of events 3 • 21 months
|
|
Infections and infestations
Trichomoniasis
|
1.4%
4/287 • Number of events 4 • 21 months
|
0.35%
1/285 • Number of events 1 • 21 months
|
0.34%
1/292 • Number of events 1 • 21 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/287 • 21 months
|
0.00%
0/285 • 21 months
|
1.0%
3/292 • Number of events 3 • 21 months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
4/287 • Number of events 4 • 21 months
|
0.70%
2/285 • Number of events 2 • 21 months
|
1.0%
3/292 • Number of events 3 • 21 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.2%
15/287 • Number of events 15 • 21 months
|
3.5%
10/285 • Number of events 10 • 21 months
|
4.1%
12/292 • Number of events 12 • 21 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.5%
13/287 • Number of events 13 • 21 months
|
6.0%
17/285 • Number of events 17 • 21 months
|
3.4%
10/292 • Number of events 10 • 21 months
|
|
Nervous system disorders
Headache
|
0.70%
2/287 • Number of events 2 • 21 months
|
1.1%
3/285 • Number of events 3 • 21 months
|
0.68%
2/292 • Number of events 2 • 21 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.35%
1/287 • Number of events 1 • 21 months
|
1.1%
3/285 • Number of events 3 • 21 months
|
0.34%
1/292 • Number of events 1 • 21 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60