Trial Outcomes & Findings for Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis (NCT NCT01361048)

NCT ID: NCT01361048

Last Updated: 2018-01-19

Results Overview

percentage of participants achieving microbiological cure of trichomonas

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: day 12-15
• Results posted on: 2018-01-19

Participant Flow

Participant milestones

Measure	Oral Metronidazole control arm	Neo Penotran Forte neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day neo penotran forte vaginal suppository once a day for 7 days
Overall Study STARTED	20	10	10
Overall Study COMPLETED	20	10	9
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Baseline characteristics by cohort

Measure	Oral Metronidazole n=20 Participants control arm	Neo Penotran Forte Twice a Day n=10 Participants neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day n=10 Participants neo penotran forte vaginal suppository once a day for 7 days	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	31.9 years STANDARD_DEVIATION 11.8 • n=5 Participants	31.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	28.3 years STANDARD_DEVIATION 6.7 • n=5 Participants	30.5 years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	40 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
Region of Enrollment United States	20 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	40 participants n=4 Participants

PRIMARY outcome

Timeframe: day 12-15

percentage of participants achieving microbiological cure of trichomonas

Outcome measures

Measure	Oral Metronidazole 2 gm Stat Dose n=20 Participants control arm	Neo Penotran Forte n=10 Participants neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day n=9 Participants neo penotran forte vaginal suppository once a day for 7 days
Percentage of Participants Cured of Vaginal Trichmonas	90 percentage of participants	90 percentage of participants	88 percentage of participants

SECONDARY outcome

Timeframe: day 12-15 day 30-35

Number of participants with any side effects

Outcome measures

Measure	Oral Metronidazole 2 gm Stat Dose n=20 Participants control arm	Neo Penotran Forte n=10 Participants neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day n=9 Participants neo penotran forte vaginal suppository once a day for 7 days
Tolerability of the Study Product as Measured by Participant Self-report	2 Participants	1 Participants	0 Participants

Adverse Events

Oral Metronidazole

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Neo Penotran Forte

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Neo Penotran Forte Once a Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Metronidazole n=20 participants at risk control arm	Neo Penotran Forte n=10 participants at risk neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day n=10 participants at risk neo penotran forte vaginal suppository once a day for 7 days
Psychiatric disorders suicicdal ideation	5.0% 1/20 • Number of events 1	0.00% 0/10	0.00% 0/10

Other adverse events

Measure	Oral Metronidazole n=20 participants at risk control arm	Neo Penotran Forte n=10 participants at risk neo penotran forte vaginal suppository twice a day for 7 days	Neo Penotran Forte Once a Day n=10 participants at risk neo penotran forte vaginal suppository once a day for 7 days
Reproductive system and breast disorders vaginal itch	10.0% 2/20 • Number of events 2	10.0% 1/10 • Number of events 1	0.00% 0/10

Additional Information

Dr. Jane Schwebke

UAB

Phone: 205-975-5665

Email: schwebke@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place