Infectious Vaginosis, Vaginitis
Conditions
Keywords
Vaginitis, Infectious vaginosis, Terconazole, Clindamycin, Fluocinolone, Metronidazole, Nystatin
Brief summary
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).
Detailed description
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, parallel (a clinical trial comparing the response in 2 or more groups of participants receiving different treatments) double-arm, multi-center (when more than 1 hospital or medical school team work on a medical research study) study. The study consists of 3 phases: Screening phase on Visit 1 (Day -3/1); Inclusion or treatment phase on Visit 2 (Day 1); and Treatment or monitoring phase (3 days after treatment) on Visit 3 (Day 7 for Gynoclin V and Day 13 for Vagitrol V) and Visit 4 (Day 12 for Gynoclin V and Day 18 for Vagitrol V). Participants will be randomly assigned to 1 of the 2 treatment groups: Gynoclin V and Vagitrol V. Participants in Gynoclin V group will be administered 1 ovule (containing 80 milligram \[mg\] terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide) vaginally every 24 hours at night, for 3 days. Participants in the Vagitrol V group will be administered 1 ovule (containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin) vaginally every 24 hours at night, for 10 days. Primarily, participants will be evaluated for signs and symptoms, characteristics of vaginal discharge, changes in vulvar region, changes in cervix and presence of bacteria, fungi and/or parasites. Participants' safety will be monitored throughout the study.
Interventions
DRUGGynoclin V
One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.
DRUGVagitrol V
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.
Sponsors
Janssen-Cilag, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants presenting clinical symptoms compatible with vaginitis/bacterial vaginosis, with any of the following symptoms being the reason for the consultation: pruritus (itchiness), vulvar burning, as well as presenting leukorrhea (a clear or white discharge from the vagina, consisting mainly of mucus) as an accompanying symptom * Participant who agrees to return at the 7th and 13th day after starting the treatment * Participant who agrees to abstain from sexual relations for the 13 days of the study * Participant who have signed informed consent to participate in the study
Exclusion criteria
* Participant with a known allergy to vaginal treatments * Participants who have received treatment for the current condition in the 10 days before the date of inclusion, or is currently receiving antibiotics (drug used to stop or slow down the growth of germs), antifungals, anti-parasitics or systemic steroids * Participant with suspected pregnancy or currently breastfeeding * Participant who has received unknown drugs or experimental drugs within the 3 months before inclusion * Participant known to be a carrier of a severe (very serious, life threatening) disease that alters the metabolism or excretion of the drugs used (liver or kidney disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) 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. | 81 |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) 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. | 79 |
| Total | 160 |
Baseline characteristics
| Characteristic | Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Total |
|---|---|---|---|
| Age Continuous | 30.69 Years STANDARD_DEVIATION 7.17 | 30.56 Years STANDARD_DEVIATION 7.5 | 30.63 Years STANDARD_DEVIATION 7.33 |
| Sex: Female, Male Female | 81 Participants | 79 Participants | 160 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 81 | 1 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
Primary
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Itching: Absent | 67.1 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Itching: Present | 32.9 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Burning: Absent | 78.5 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Burning: Present | 21.5 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Sudden vulvar pain: Absent | 95.0 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Sudden vulvar pain: Present | 5.0 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Sudden vulvar pain: Absent | 90.9 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Itching: Absent | 79.2 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Burning: Present | 11.7 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Itching: Present | 20.8 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Sudden vulvar pain: Present | 9.1 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment | Burning: Absent | 88.3 Percentage of Participants |
Primary
Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Itching: Absent | 88.3 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Itching: Present | 11.7 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Burning: Absent | 93.5 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Burning: Present | 6.5 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Sudden vulvar pain: Absent | 97.4 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Sudden vulvar pain: Present | 2.6 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Sudden vulvar pain: Absent | 89.3 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Itching: Absent | 85.3 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Burning: Present | 8 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Itching: Present | 14.7 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Sudden vulvar pain: Present | 10.7 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment | Burning: Absent | 92 Percentage of Participants |
Primary
Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | 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 | 9.8 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Lactobacillus species | 28.4 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Vaginal Flora | 55.6 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | No culture performed | 3.7 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Candida albicans | 2.5 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | No culture performed | 3.8 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Candida albicans | 0 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | 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 | 1.3 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Vaginal Flora | 58.2 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment | Lactobacillus species | 36.7 Percentage of Participants |
Secondary
Percentage of Participants With Response to Treatment Assessed by Participant
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Participant | Poor | 1.30 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Participant | Moderate | 0 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Participant | Good | 36.40 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Participant | Excellent | 62.30 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Participant | Excellent | 65.30 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Participant | Poor | 1.30 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Participant | Good | 29.40 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Participant | Moderate | 4.00 Percentage of Participants |
Secondary
Percentage of Participants With Response to Treatment Assessed by Physician
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Physician | Poor | 1.30 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Physician | Moderate | 0 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Physician | Good | 28.60 Percentage of Participants |
| Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) | Percentage of Participants With Response to Treatment Assessed by Physician | Excellent | 70.10 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Physician | Excellent | 66.70 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Physician | Poor | 1.30 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Physician | Good | 26.70 Percentage of Participants |
| Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) | Percentage of Participants With Response to Treatment Assessed by Physician | Moderate | 5.30 Percentage of Participants |