Trial Outcomes & Findings for A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis (NCT NCT03935217)
NCT ID: NCT03935217
Last Updated: 2023-10-04
Results Overview
Vaginal Culture negative for T. vaginalis at TOC Visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Study Day 6-12
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Solosec 2 Grams
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole
|
Placebo
Orally administered as a single dose with applesauce.
Placebo: Oral Granules of placebo manufactured to mimic secnidazole
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
73
|
|
Overall Study
COMPLETED
|
73
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Solosec 2 Grams
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole
|
Placebo
Orally administered as a single dose with applesauce.
Placebo: Oral Granules of placebo manufactured to mimic secnidazole
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
Baseline characteristics by cohort
| Measure |
Solosec 2 Grams
n=74 Participants
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole then
|
Placebo
n=73 Participants
Orally administered as a single dose with applesauce.
Placebo: Oral Granules of placebo manufactured to mimic secnidazole then
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 0 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
74 participants
n=5 Participants
|
73 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Number of Participants for Modified intent to treat population
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 6-12Population: Modified Intent to Treat Population (Patients with culture positive for T. vaginalis at baseline)
Vaginal Culture negative for T. vaginalis at TOC Visit
Outcome measures
| Measure |
Solosec 2 Grams
n=64 Participants
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole
|
Placebo
n=67 Participants
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole
|
|---|---|---|
|
Microbiological Cure at the TOC Visit
|
59 Participants
|
1 Participants
|
Adverse Events
Solosec (Containing 2 Grams of Secnidazole)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Solosec (Containing 2 Grams of Secnidazole)
n=74 participants at risk
Orally administered as a single dose with applesauce.
Secnidazole: Oral Granules containing secnidazole
|
Placebo
n=73 participants at risk
Orally administered as a single dose with applesauce.
Placebo: Oral Granules of placebo manufactured to mimic secnidazole
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/74 • Number of events 2 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
4.1%
3/73 • Number of events 3 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/74 • Number of events 1 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
2.7%
2/73 • Number of events 2 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
|
Infections and infestations
Vulvovagnial candidiasis
|
2.7%
2/74 • Number of events 2 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
0.00%
0/73 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/74 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
2.7%
2/73 • Number of events 2 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
|
Nervous system disorders
Headache
|
1.4%
1/74 • Number of events 1 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
6.8%
5/73 • Number of events 5 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/74 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
2.7%
2/73 • Number of events 2 • Data includes AEs reported during the primary phase of study [Visit 1 (baseline) to TOC/Visit 2 (day 6-12)] for each study patient.
Adverse Event data reported for primary phase of study only. Subjects received either Solosec or Placebo (1:1) during primary phase of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place