Vulvovaginal Candidiasis, GenitalPhase 3NCT06411314
Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
A Phase 3 study testing Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Lactulose 300 mg vaginal suppositories and Pimafucin® (natamycin) 100 mg vaginal suppositories in people with Vulvovaginal Candidiasis, Genital, run by Avva Rus, JSC at 1 site in Russia.
Trial summary
The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis, Genital
- What is being tested?
- Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Lactulose 300 mg vaginal suppositories and Pimafucin® (natamycin) 100 mg vaginal suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteRussia
- Study dates
- 29 Dec 2022to 22 Sep 2023
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- two or more of the following signs and symptoms of vulvovaginal candidiasis: white or yellowish-white curd-like, thick or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination (dysuria);
- yeast cells in the vaginal swab specimen;
- vaginal pH ≤ 4.5.
Who cannot join
- a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University
Moscow
About this study
Official title: Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial
The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.
- Conditions
- Vulvovaginal Candidiasis, Genital
- Being tested
- Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Lactulose 300 mg vaginal suppositories, Pimafucin® (natamycin) 100 mg vaginal suppositories
- Keywords
- vulvovaginal candidiasis, itching, Natamycin, Lactulose
- Medical subject headings
- Candidiasis, Vulvovaginal, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natamycin + Lactulose 100 mg + 300 mg vaginal suppositoriesCombination product
1 suppository once daily at bedtime for 6 days
Lactulose 300 mg vaginal suppositoriesDrug
1 suppository once daily at bedtime for 6 days
Pimafucin® (natamycin) 100 mg vaginal suppositoriesDrug
1 suppository once daily at bedtime for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories | Experimental | Not described Receives: Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories |
| Lactulose 300 mg vaginal suppositories | Active comparator | Not described Receives: Drug: Lactulose 300 mg vaginal suppositories |
| Pimafucin® (natamycin) 100 mg vaginal suppositories | Active comparator | Not described Receives: Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination [dysuria])
Measured: 7 days
Secondary outcomes (6)
Proportion (%) of patients with the clinical response at Visit 3
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination [dysuria])
Measured: 24 days
Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3
The vaginal culture test for Candida spp. was used for the microscopic assessment
Measured: 24 days
Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3
The vaginal culture test was used for the microscopic assessment
Measured: 24 days
Patient's efficacy assessment by the 5-point scale at Visits 2, 3
The patient completed a questionnaire in the presence of the investigating physician as part of the efficacy assessment. The questionnaire contained closed-ended responses ranging from 1 point (no clinical symptoms) to 5 points (severe clinical symptoms)
Measured: 24 days
Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)
Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3
Measured: 24 days
Incidence of adverse events
incidence of any adverse events, an incidence of serious adverse events (SAEs), an incidence of AEs and SAEs probably related (in the investigator's opinion) with the study drug at the study dose, and an incidence of AEs and SAEs that led to study drug discontinuation.
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start29 Dec 2022
- Primary completion26 Jul 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal Candidiasis, GenitalStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avva Rus, JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411314
- Sponsor's protocol ID
- 12/21-AVVA RUS
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Volkova ON, Amel'chenko EV, Makeeva OV, Tolmachev SA, Lesovaya EA, Zacharia LC, Dikovskiy AV. Efficacy and safety of vaginal suppositories containing combination of Natamycin and Lactulose in treatment of vulvovaginal candidiasis: international, randomized, controlled, superiority clinical trial (combination of Natamycin and Lactulose for treatment of vulvovaginal candidiasis). BMC Womens Health. 2025 Feb 20;25(1):77. doi: 10.1186/s12905-025-03616-3.
PubMed 39979898
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06411314
- Acronym / sponsor ID
- 12/21-AVVA RUS
- Conditions
- Vulvovaginal Candidiasis, Genital
- Keywords
- vulvovaginal candidiasis, itching, Natamycin, Lactulose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Avva Rus, JSCIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 13 May 2024 (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.
The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories | Experimental | Combination Product: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories |
| Lactulose 300 mg vaginal suppositories | Active comparator | Drug: Lactulose 300 mg vaginal suppositories |
| Pimafucin® (natamycin) 100 mg vaginal suppositories | Active comparator | Drug: Pimafucin® (natamycin) 100 mg vaginal suppositories |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- two or more of the following signs and symptoms of vulvovaginal candidiasis: white or yellowish-white curd-like, thick or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination (dysuria);
- yeast cells in the vaginal swab specimen;
- vaginal pH ≤ 4.5.
Key exclusion criteria (1 listed)
- a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.
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 |
|---|---|---|
| Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories1 suppository once daily at bedtime for 6 days | Combination product | Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories |
| Lactulose 300 mg vaginal suppositories1 suppository once daily at bedtime for 6 days | Drug | Lactulose 300 mg vaginal suppositories |
| Pimafucin® (natamycin) 100 mg vaginal suppositories1 suppository once daily at bedtime for 6 days | Drug | Pimafucin® (natamycin) 100 mg vaginal suppositories |
Primary outcome
Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
Time frame: 7 days
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination [dysuria])
6 secondary outcomes
Proportion (%) of patients with the clinical response at Visit 3
Time frame: 24 days
Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3
Time frame: 24 days
Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3
Time frame: 24 days
Patient's efficacy assessment by the 5-point scale at Visits 2, 3
Time frame: 24 days
Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)
Time frame: 24 days
Incidence of adverse events
Time frame: 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 39979898Volkova ON, Amel'chenko EV, Makeeva OV, Tolmachev SA, Lesovaya EA, Zacharia LC, Dikovskiy AV. Efficacy and safety of vaginal suppositories containing combination of Natamycin and Lactulose in treatment of vulvovaginal candidiasis: international, randomized, controlled, superiority clinical trial (combination of Natamycin and Lactulose for treatment of vulvovaginal candidiasis). BMC Womens Health. 2025 Feb 20;25(1):77. doi: 10.1186/s12905-025-03616-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Lactulose 300 mg vaginal suppositories and Pimafucin® (natamycin) 100 mg vaginal suppositories in people with Vulvovaginal Candidiasis, Genital, run by Avva Rus, JSC at 1 site in Russia.
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 3 inclusion and 1 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2 (time frame: 7 days). 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 NCT06411314, which also lists 1 linked publication.
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 13 May 2024.