Acute Vulvovaginal CandidiasisPhase 2NCT04813822
Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
A Phase 2 study testing Miconazole Nitrate 2% + Domiphen Bromide Low Dose, Miconazole Nitrate 2% + Domiphen Bromide High Dose and Miconazole Nitrate 2% in people with Acute Vulvovaginal Candidiasis, run by Aesculape CRO Belgium BV at 6 sites in Belgium.
Trial summary
This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acute Vulvovaginal Candidiasis
- What is being tested?
- Miconazole Nitrate 2% + Domiphen Bromide Low Dose, Miconazole Nitrate 2% + Domiphen Bromide High Dose and Miconazole Nitrate 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesBelgium
- Study dates
- 13 Sep 2021to Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Main inclusion criteria:
- Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
- Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
Main exclusion criteria :
- Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
- Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
- Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response.
- Subjects with a history of cervical cancer.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Recruiting
Fertiliteitscentrum Dr. Decleer Aalter
Aalter, East Flanders, 9880
Wim Decleer, MD
- Recruiting
Dr. Philip Loquet, Private practice - Gynaecology
Antwerp, 2018
Philip Loquet, Dr.
- Recruiting
Dr. Goessens - Dr. Houben, Private practice - Gynaecology
Bruges, West Flanders, 8000
Luc Goessens, MD
- Recruiting
UZ Antwerpen - Gynaecology department
Edegem, Antwerpen, 2650
Gilbert Donders, Prof. dr.
- Recruiting
UZ Gent - Gynaecology department
Ghent, East Flanders, 9000
Hans Verstraelen, Prof. Dr.
- Recruiting
Femicare vzw
Tienen, Brabant, 3300
Gilbert Donders, Prof. Dr.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.
Read the detailed description
Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.
- Conditions
- Acute Vulvovaginal Candidiasis
- Being tested
- Miconazole Nitrate 2% + Domiphen Bromide Low Dose, Miconazole Nitrate 2% + Domiphen Bromide High Dose, Miconazole Nitrate 2%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miconazole Nitrate 2% + Domiphen Bromide Low DoseDrug
Dosage 1
Miconazole Nitrate 2% + Domiphen Bromide High DoseDrug
Dosage 2
Miconazole Nitrate 2%Drug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream | Experimental | The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. Receives: Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose |
| Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream | Experimental | The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. Receives: Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose |
| Gyno-Daktarin® Vaginal Cream | Active comparator | The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. Receives: Drug: Miconazole Nitrate 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Measured: First follow-up visit (Day 15)
The proportion of subjects with mycological eradication
A culture negative vaginal swab for growth of baseline Candida species
Measured: First follow-up visit (Day 15)
The proportion of subjects with overall therapeutic success
Achievement of both clinical cure and mycological eradication
Measured: First follow-up visit (Day 15)
Secondary outcomes (5)
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Measured: First follow-up visit through Week 12
The proportion of subjects with mycological eradication
A culture negative vaginal swab for growth of baseline Candida species at Day 15, a culture and PCR negative vaginal swab for growth of baseline Candida species on the Other follow-up visits
Measured: First follow-up visit through Week 12
The proportion of subjects with overall therapeutic success
Achievement of both clinical cure and mycological eradication
Measured: First follow-up visit through Week 12
Change from Baseline in vulvovaginitis symptom questionnaire total score
VSQ: Vulvovaginal symptoms questionnaire
Measured: Through Week 12
Change from Baseline in the EQ-5D questionnaire total score
EQ-5D: health-related quality of life questionnaire
Measured: Through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start13 Sep 2021
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Vulvovaginal CandidiasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculape CRO Belgium BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Deslypere, MD, Study director, Aesculape CRO Belgium BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813822
- Sponsor's protocol ID
- FHP-2021-2-26
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT04813822
- Acronym / sponsor ID
- FHP-2021-2-26
- Conditions
- Acute Vulvovaginal Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aesculape CRO Belgium BVIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.
Detailed description
Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream | Experimental | Drug: Miconazole Nitrate 2% + Domiphen Bromide Low DoseThe content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. |
| Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream | Experimental | Drug: Miconazole Nitrate 2% + Domiphen Bromide High DoseThe content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. |
| Gyno-Daktarin® Vaginal Cream | Active comparator | Drug: Miconazole Nitrate 2%The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Miconazole Nitrate 2% + Domiphen Bromide Low DoseDosage 1 | Drug | Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream |
| Miconazole Nitrate 2% + Domiphen Bromide High DoseDosage 2 | Drug | Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream |
| Miconazole Nitrate 2%Active Comparator | Drug | Gyno-Daktarin® Vaginal Cream |
Primary outcome
The proportion of subjects with clinical cure
Time frame: First follow-up visit (Day 15)
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with mycological eradication
Time frame: First follow-up visit (Day 15)
A culture negative vaginal swab for growth of baseline Candida species
The proportion of subjects with overall therapeutic success
Time frame: First follow-up visit (Day 15)
Achievement of both clinical cure and mycological eradication
5 secondary outcomes
The proportion of subjects with clinical cure
Time frame: First follow-up visit through Week 12
The proportion of subjects with mycological eradication
Time frame: First follow-up visit through Week 12
The proportion of subjects with overall therapeutic success
Time frame: First follow-up visit through Week 12
Change from Baseline in vulvovaginitis symptom questionnaire total score
Time frame: Through Week 12
Change from Baseline in the EQ-5D questionnaire total score
Time frame: Through Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Jean-Paul Deslypere, MD study director
Aesculape CRO Belgium BV
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miconazole Nitrate 2% + Domiphen Bromide Low Dose, Miconazole Nitrate 2% + Domiphen Bromide High Dose and Miconazole Nitrate 2% in people with Acute Vulvovaginal Candidiasis, run by Aesculape CRO Belgium BV at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul Deslypere, MD (+32492735931, jpdeslypere@aesculape.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with clinical cure (time frame: First follow-up visit (Day 15)). 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?
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 14 Mar 2022.