Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT01361048
• Collaborator: Embil Pharmaceutical Co. Ltd (Industry)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.

Condition or Disease	Intervention/Treatment	Phase
Trichomonas Vaginitis	Drug: oral metronidazole; Drug: neo penotran forte; Drug: neo penotran forte once a day	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oral metronidazole control arm	Drug: oral metronidazole; 2 gm oral once
Experimental: neo penotran forte neo penotran forte vaginal suppository twice a day for 7 days	Drug: neo penotran forte; neo penotran forte intravaginal twice a day for 7 days
Experimental: neo penotran forte once a day neo penotran forte vaginal suppository once a day for 7 days	Drug: neo penotran forte once a day; neo penotran forte intravaginally once a day for 7 days

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Cured of Vaginal Trichmonas [day 12-15]

   percentage of participants achieving microbiological cure of trichomonas

Secondary Outcome Measures

1. Tolerability of the Study Product as Measured by Participant Self-report [day 12-15 day 30-35]

   Number of participants with any side effects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• presence of trichomonas

Exclusion Criteria:

• pregnant or nursing

• known immunodeficiency

• allergy to study drugs

• concurrent yeast infection

• history of seizures or peripheral neuropathy

• unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium

• anticoagulation therapy, and abuse

• patient expected to have menses within 8 days of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Personal Health Clinic UAB	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Embil Pharmaceutical Co. Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jane Schwebke, Professor of Medicine, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01361048
• Other Study ID Numbers: TV-01
• First Posted: May 26, 2011
• Last Update Posted: Jan 19, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Jane Schwebke, Professor of Medicine, University of Alabama at Birmingham: trichomonas
• Additional relevant MeSH terms: Trichomonas Infections; Trichomonas Vaginitis; Vaginitis; Metronidazole

Study Results

Participant Flow

Arm/Group Title	Oral Metronidazole	Neo Penotran Forte	Neo Penotran Forte Once a Day
Arm/Group Description	control arm	neo penotran forte vaginal suppository twice a day for 7 days	neo penotran forte vaginal suppository once a day for 7 days
Period Title: Overall Study
STARTED	20	10	10
COMPLETED	20	10	9
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Oral Metronidazole	Neo Penotran Forte Twice a Day	Neo Penotran Forte Once a Day	Total
Arm/Group Description	control arm	neo penotran forte vaginal suppository twice a day for 7 days	neo penotran forte vaginal suppository once a day for 7 days	Total of all reporting groups
Overall Participants	20	10	10	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	10 100%	10 100%	40 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.9 (11.8)	31.5 (9.8)	28.3 (6.7)	30.5 (10.5)
Sex: Female, Male (Count of Participants)
Female	20 100%	10 100%	10 100%	40 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	10 100%	10 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Cured of Vaginal Trichmonas
Description	percentage of participants achieving microbiological cure of trichomonas
Time Frame	day 12-15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Metronidazole 2 gm Stat Dose	Neo Penotran Forte	Neo Penotran Forte Once a Day
Arm/Group Description	control arm	neo penotran forte vaginal suppository twice a day for 7 days	neo penotran forte vaginal suppository once a day for 7 days
Measure Participants	20	10	9
Number [percentage of participants]	90 450%	90 900%	88 880%

2. Secondary Outcome

Title	Tolerability of the Study Product as Measured by Participant Self-report
Description	Number of participants with any side effects
Time Frame	day 12-15 day 30-35

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Metronidazole	Neo Penotran Forte	Neo Penotran Forte Once a Day
Arm/Group Description	control arm oral metronidazole: 2 gm oral once	neo penotran forte vaginal suppository twice a day for 7 days neo penotran forte: neo penotran forte intravaginal twice a day for 7 days	neo penotran forte vaginal suppository once a day for 7 days neo penotran forte once a day: neo penotran forte intravaginally once a day for 7 days
Measure Participants	20	10	9
Count of Participants [Participants]	2 10%	1 10%	0 0%

Adverse Events

Arm/Group Title	Oral Metronidazole		Neo Penotran Forte		Neo Penotran Forte Once a Day
Arm/Group Description	control arm		neo penotran forte vaginal suppository twice a day for 7 days		neo penotran forte vaginal suppository once a day for 7 days
All Cause Mortality
	Oral Metronidazole		Neo Penotran Forte		Neo Penotran Forte Once a Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Oral Metronidazole		Neo Penotran Forte		Neo Penotran Forte Once a Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/10 (0%)		0/10 (0%)
Psychiatric disorders
suicicdal ideation	1/20 (5%)	1	0/10 (0%)	0	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Oral Metronidazole		Neo Penotran Forte		Neo Penotran Forte Once a Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		1/10 (10%)		0/10 (0%)
Reproductive system and breast disorders
vaginal itch	2/20 (10%)	2	1/10 (10%)	1	0/10 (0%)	0

Limitations/Caveats

pilot study

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.