Trial Outcomes & Findings for Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection (NCT NCT04553068)
NCT ID: NCT04553068
Last Updated: 2024-01-30
Results Overview
Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1892 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
EVO100 Gel
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
|---|---|---|
|
Overall Study
STARTED
|
943
|
949
|
|
Overall Study
COMPLETED
|
792
|
805
|
|
Overall Study
NOT COMPLETED
|
151
|
144
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
Baseline characteristics by cohort
| Measure |
EVO100 Gel
n=943 Participants
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
n=949 Participants
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
Total
n=1892 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 10.31 • n=93 Participants
|
29.7 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
29.6 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
943 Participants
n=93 Participants
|
949 Participants
n=4 Participants
|
1892 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
467 Participants
n=93 Participants
|
447 Participants
n=4 Participants
|
914 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
461 Participants
n=93 Participants
|
482 Participants
n=4 Participants
|
943 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
243 Participants
n=93 Participants
|
253 Participants
n=4 Participants
|
496 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
608 Participants
n=93 Participants
|
615 Participants
n=4 Participants
|
1223 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
35 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
943 participants
n=93 Participants
|
949 participants
n=4 Participants
|
1892 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: mITT
Percentage of subjects who are defined study successes among the intervention groups with success defined as subjects completing the trial to Visit 5 without any CT or GC infection and no usage of prohibited antibiotics during the study.
Outcome measures
| Measure |
EVO100 Gel
n=906 Participants
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
n=913 Participants
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
|---|---|---|
|
Percentage of Study Successes in the EVO100 and Placebo Treatment Groups
|
684 Participants
|
696 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Safety
Descriptive analysis of AEs
Outcome measures
| Measure |
EVO100 Gel
n=926 Participants
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
n=937 Participants
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
|---|---|---|
|
Evaluate Safety of EVO100: AEs
Serious TEAEs
|
4 participants
|
9 participants
|
|
Evaluate Safety of EVO100: AEs
SAEs
|
2 participants
|
2 participants
|
|
Evaluate Safety of EVO100: AEs
Treatment related AEs
|
81 participants
|
62 participants
|
|
Evaluate Safety of EVO100: AEs
Deaths
|
0 participants
|
0 participants
|
Adverse Events
EVO100 Gel
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVO100 Gel
n=926 participants at risk
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
n=937 participants at risk
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
ectopic pregnancy
|
0.22%
2/926 • Number of events 2 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Blood and lymphatic system disorders
blood loss anemia
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Nervous system disorders
alcohol poisoning
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Injury, poisoning and procedural complications
craniocerebral injury
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Injury, poisoning and procedural complications
fall
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Reproductive system and breast disorders
adenomyosis
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.11%
1/926 • Number of events 1 • 16 weeks
|
0.00%
0/937 • 16 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Reproductive system and breast disorders
fallopian tube abscess
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Reproductive system and breast disorders
tubo-ovarian abscess
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Hepatobiliary disorders
pancreatic contusion
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
|
Pregnancy, puerperium and perinatal conditions
abortion missed
|
0.00%
0/926 • 16 weeks
|
0.21%
2/937 • Number of events 2 • 16 weeks
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
0.00%
0/926 • 16 weeks
|
0.11%
1/937 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
EVO100 Gel
n=926 participants at risk
EVO100 vaginal gel, 5 g
EVO100: EVO100 vaginal gel
|
Placebo Gel
n=937 participants at risk
Placebo vaginal gel, 5 g
Placebo: Placebo vaginal gel
|
|---|---|---|
|
Reproductive system and breast disorders
vaginal discharge
|
4.2%
39/926 • Number of events 39 • 16 weeks
|
3.0%
28/937 • Number of events 28 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place