VaginitisPhase 3NCT01867164

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

A Phase 3 study testing Gynoclin V and Vagitrol V in people with Vaginitis and Infectious Vaginosis, run by Janssen-Cilag, S.A. at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Vaginitis, Infectious Vaginosis
What is being tested?: Gynoclin V and Vagitrol V
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesMexico
Study dates: Dec 2007to Dec 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

Study site
DF, Mexico City
Study site
Mexico City

Other trials in Mexico

About this study

Official title: A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)

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).

Read the 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.

Conditions: Vaginitis, Infectious Vaginosis
Being tested: Gynoclin V, Vagitrol V
Keywords: Vaginitis, Infectious vaginosis, Terconazole, Clindamycin, Fluocinolone, Metronidazole, Nystatin
Medical subject headings: Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gynoclin VDrug
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.
Vagitrol VDrug
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.

Study groups in NCT01867164
Study group	Role	What they receive
Gynoclin V	Experimental	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. Receives: Drug: Gynoclin V
Vagitrol V	Experimental	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. Receives: Drug: Vagitrol V

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)
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.
Measured: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
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.
Measured: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)

Secondary outcomes (2)

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).
Measured: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
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).
Measured: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Dec 2008

First posted3 Jun 2013 (estimated)
Study startDec 2007
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for VaginitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01867164
Sponsor's protocol ID: CR100569
Other IDs: TEROV8BAC4001
Status last verified: Nov 2013
First submitted: 29 May 2013
Last updated: 24 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

All Vaginitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)
ClinicalTrials.gov ID: NCT01867164
Acronym / sponsor ID: CR100569
Conditions: Vaginitis, Infectious Vaginosis
Keywords: Vaginitis, Infectious vaginosis, Terconazole, Clindamycin, Fluocinolone, Metronidazole, Nystatin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 3 Jun 2013 (estimated)
Results: Posted 24 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gynoclin V	Experimental	Drug: Gynoclin VOne 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.
Vagitrol V	Experimental	Drug: Vagitrol VOne 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.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gynoclin VOne 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.	Drug	Gynoclin V
Vagitrol VOne 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.	Drug	Vagitrol V

Primary outcome

Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Time frame: 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
Time frame: 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
Time frame: 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.

2 secondary outcomes

Percentage of Participants With Response to Treatment Assessed by Participant
Time frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
Percentage of Participants With Response to Treatment Assessed by Physician
Time frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)

Results and safety

Results posted to the registry on 24 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)	81	81
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)	79	79

Primary outcome: Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment

Time frame: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V). Number. Unit: Percentage of Participants

Measure	Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) n = 79	Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) n = 77
Itching: Absent	67.1	79.2
Itching: Present	32.9	20.8
Burning: Absent	78.5	88.3
Burning: Present	21.5	11.7
Sudden vulvar pain: Absent	95.0	90.9
Sudden vulvar pain: Present	5.0	9.1

Population analysed: 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.

Primary outcome: Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment

Time frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V). Number. Unit: Percentage of Participants

Measure	Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) n = 77	Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) n = 75
Itching: Absent	88.3	85.3
Itching: Present	11.7	14.7
Burning: Absent	93.5	92
Burning: Present	6.5	8
Sudden vulvar pain: Absent	97.4	89.3
Sudden vulvar pain: Present	2.6	10.7

Population analysed: 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.

Primary outcome: Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment

Time frame: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V). Number. Unit: Percentage of Participants

Measure	Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) n = 78	Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) n = 76
Candida albicans	2.5	0
Candida species, Gardnerella vaginalis	9.8	1.3
Vaginal Flora	55.6	58.2
Lactobacillus species	28.4	36.7
No culture performed	3.7	3.8

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)	0 of 81 (0%)	1 of 81 (1.2%)	Not reported
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)	0 of 79 (0%)	1 of 79 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vaginitis

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen-Cilag S.A. Clinical Trial study director

Janssen-Cilag, S.A.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gynoclin V and Vagitrol V in people with Vaginitis and Infectious Vaginosis, run by Janssen-Cilag, S.A. at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment (time frame: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01867164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.