Trial · NCT01361048
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
NCT01361048, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2014-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis. Trials, record NCT01361048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01361048
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
- NCT number
- NCT01361048
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Trichomonas Vaginitis
- Interventions
- oral metronidazole, neo penotran forte, neo penotran forte once a day
- First posted
- 2011-05-26
- Last updated
- 2018-01-19
- Results first posted
- 2014-02-20
- Limitations and caveats
- pilot study
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Cured of Vaginal Trichmonas | day 12-15 | percentage of participants achieving microbiological cure of trichomonas |
| Secondary | Tolerability of the Study Product as Measured by Participant Self-report | day 12-15 day 30-35 | Number of participants with any side effects |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Cured of Vaginal Trichmonas | day 12-15 | percentage of participants | NUMBER | |
| SECONDARY | Tolerability of the Study Product as Measured by Participant Self-report | day 12-15 day 30-35 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Cured of Vaginal Trichmonas | Oral Metronidazole 2 gm Stat Dose | 90 | percentage of participants | ||
| Percentage of Participants Cured of Vaginal Trichmonas | Neo Penotran Forte | 90 | percentage of participants | ||
| Percentage of Participants Cured of Vaginal Trichmonas | Neo Penotran Forte Once a Day | 88 | percentage of participants | ||
| Tolerability of the Study Product as Measured by Participant Self-report | Oral Metronidazole | 2 | Participants | ||
| Tolerability of the Study Product as Measured by Participant Self-report | Neo Penotran Forte | 1 | Participants | ||
| Tolerability of the Study Product as Measured by Participant Self-report | Neo Penotran Forte Once a Day | 0 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Metronidazole | 20 | |
| Overall Study | STARTED | Neo Penotran Forte | 10 | |
| Overall Study | STARTED | Neo Penotran Forte Once a Day | 10 | |
| Overall Study | COMPLETED | Oral Metronidazole | 20 | |
| Overall Study | COMPLETED | Neo Penotran Forte | 10 | |
| Overall Study | COMPLETED | Neo Penotran Forte Once a Day | 9 | |
| Overall Study | NOT COMPLETED | Oral Metronidazole | 0 | |
| Overall Study | NOT COMPLETED | Neo Penotran Forte | 0 | |
| Overall Study | NOT COMPLETED | Neo Penotran Forte Once a Day | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | vaginal itch | Reproductive system and breast disorders | Oral Metronidazole | 2 | 20 | 2 |
| other | vaginal itch | Reproductive system and breast disorders | Neo Penotran Forte | 1 | 10 | 1 |
| other | vaginal itch | Reproductive system and breast disorders | Neo Penotran Forte Once a Day | 0 | 10 | 0 |
| serious | suicicdal ideation | Psychiatric disorders | Oral Metronidazole | 1 | 20 | 1 |
| serious | suicicdal ideation | Psychiatric disorders | Neo Penotran Forte | 0 | 10 | 0 |
| serious | suicicdal ideation | Psychiatric disorders | Neo Penotran Forte Once a Day | 0 | 10 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Metronidazole | ||
| Total, all-cause mortality | Neo Penotran Forte | ||
| Total, all-cause mortality | Neo Penotran Forte Once a Day | ||
| Total, other adverse events | Oral Metronidazole | 2 | 20 |
| Total, other adverse events | Neo Penotran Forte | 1 | 10 |
| Total, other adverse events | Neo Penotran Forte Once a Day | 0 | 10 |
| Total, serious adverse events | Oral Metronidazole | 1 | 20 |
| Total, serious adverse events | Neo Penotran Forte | 0 | 10 |
| Total, serious adverse events | Neo Penotran Forte Once a Day | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01361048
GET https://conductscience.org/api/trials/v1/NCT01361048/registered