Trial Outcomes & Findings for 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 NCT01867164)
NCT ID: NCT01867164
Last Updated: 2013-12-24
Results Overview
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
COMPLETED
PHASE3
160 participants
3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)
2013-12-24
Participant Flow
Participant milestones
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
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|---|---|---|
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Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
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81
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=81 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=79 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
|
Total
n=160 Participants
Total of all reporting groups
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|---|---|---|---|
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Age Continuous
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30.69 Years
STANDARD_DEVIATION 7.17 • n=5 Participants
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30.56 Years
STANDARD_DEVIATION 7.50 • n=7 Participants
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30.63 Years
STANDARD_DEVIATION 7.33 • n=5 Participants
|
|
Sex: Female, Male
Female
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81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)Population: 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.
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Outcome measures
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=79 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=77 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
|
|---|---|---|
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Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Itching: Absent
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67.1 Percentage of Participants
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79.2 Percentage of Participants
|
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Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Itching: Present
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32.9 Percentage of Participants
|
20.8 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Burning: Absent
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78.5 Percentage of Participants
|
88.3 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Burning: Present
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21.5 Percentage of Participants
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11.7 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Sudden vulvar pain: Absent
|
95.0 Percentage of Participants
|
90.9 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Sudden vulvar pain: Present
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5.0 Percentage of Participants
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9.1 Percentage of Participants
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PRIMARY outcome
Timeframe: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)Population: 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.
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Outcome measures
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=77 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=75 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
|
|---|---|---|
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Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Itching: Absent
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88.3 Percentage of Participants
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85.3 Percentage of Participants
|
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Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Itching: Present
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11.7 Percentage of Participants
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14.7 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Burning: Absent
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93.5 Percentage of Participants
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92 Percentage of Participants
|
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Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Burning: Present
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6.5 Percentage of Participants
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8 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Sudden vulvar pain: Absent
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97.4 Percentage of Participants
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89.3 Percentage of Participants
|
|
Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Sudden vulvar pain: Present
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2.6 Percentage of Participants
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10.7 Percentage of Participants
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PRIMARY outcome
Timeframe: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)Population: 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 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.
Outcome measures
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=78 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=76 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
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|---|---|---|
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Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
Candida albicans
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2.5 Percentage of Participants
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0 Percentage of Participants
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Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
Candida species, Gardnerella vaginalis
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9.8 Percentage of Participants
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1.3 Percentage of Participants
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Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
Vaginal Flora
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55.6 Percentage of Participants
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58.2 Percentage of Participants
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Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
Lactobacillus species
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28.4 Percentage of Participants
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36.7 Percentage of Participants
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Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
No culture performed
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3.7 Percentage of Participants
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3.8 Percentage of Participants
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SECONDARY outcome
Timeframe: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)Population: 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.
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).
Outcome measures
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=77 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=75 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
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|---|---|---|
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Percentage of Participants With Response to Treatment Assessed by Participant
Poor
|
1.30 Percentage of Participants
|
1.30 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Participant
Moderate
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0 Percentage of Participants
|
4.00 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Participant
Good
|
36.40 Percentage of Participants
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29.40 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Participant
Excellent
|
62.30 Percentage of Participants
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65.30 Percentage of Participants
|
SECONDARY outcome
Timeframe: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)Population: 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.
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).
Outcome measures
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=77 Participants
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=75 Participants
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
|
|---|---|---|
|
Percentage of Participants With Response to Treatment Assessed by Physician
Poor
|
1.30 Percentage of Participants
|
1.30 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Physician
Moderate
|
0 Percentage of Participants
|
5.30 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Physician
Good
|
28.60 Percentage of Participants
|
26.70 Percentage of Participants
|
|
Percentage of Participants With Response to Treatment Assessed by Physician
Excellent
|
70.10 Percentage of Participants
|
66.70 Percentage of Participants
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Adverse Events
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)
n=81 participants at risk
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
|
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
n=79 participants at risk
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
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|---|---|---|
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Infections and infestations
Fungal Infections
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0.00%
0/81 • Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
|
1.3%
1/79 • Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
|
|
Nervous system disorders
Headache
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1.2%
1/81 • Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
|
0.00%
0/79 • Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
|
Additional Information
Clinical Research Director
Global Clinical Operations Mexico
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place