Trial · NCT01867164
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
NCT01867164, Phase 3, Completed, Janssen-Cilag, S.A.; results first posted 2013-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis. Trials, record NCT01867164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01867164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
- NCT number
- NCT01867164
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Janssen-Cilag, S.A.
- Conditions
- Vaginitis, Infectious Vaginosis
- Interventions
- Gynoclin V, Vagitrol V
- First posted
- 2013-06-03
- Last updated
- 2013-12-24
- Results first posted
- 2013-12-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. |
| Primary | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment. |
| Primary | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) | Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment. |
| Secondary | Percentage of Participants With Response to Treatment Assessed by Participant | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). |
| Secondary | Percentage of Participants With Response to Treatment Assessed by Physician | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment Assessed by Participant | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Treatment Assessed by Physician | 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) | Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Itching: Absent | 67.1 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Itching: Absent | 79.2 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Itching: Present | 32.9 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Itching: Present | 20.8 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Burning: Absent | 78.5 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Burning: Absent | 88.3 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Burning: Present | 21.5 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Burning: Present | 11.7 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Sudden vulvar pain: Absent | 95.0 | Percentage of Participants | |
| Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Sudden vulvar pain: Absent | 90.9 | Percentage of Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 81 | |
| Overall Study | STARTED | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 79 | |
| Overall Study | COMPLETED | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 81 | |
| Overall Study | COMPLETED | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 79 | |
| Overall Study | NOT COMPLETED | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 0 | |
| Overall Study | NOT COMPLETED | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Fungal Infections | Infections and infestations | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 0 | 81 | |
| other | Fungal Infections | Infections and infestations | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 1 | 79 | |
| other | Headache | Nervous system disorders | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 1 | 81 | |
| other | Headache | Nervous system disorders | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 0 | 79 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | ||
| Total, all-cause mortality | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | ||
| Total, other adverse events | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 1 | 81 |
| Total, other adverse events | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 1 | 79 |
| Total, serious adverse events | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 0 | 81 |
| Total, serious adverse events | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 0 | 79 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) vs Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin): serious adverse events |
Source Trial comparisons
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/NCT01867164
GET https://conductscience.org/api/trials/v1/NCT01867164/results?page=2