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Tests treatment safety and results for Candidal Vulvovaginitis (ICD-10 Code: B37.3)
Official title Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
ClinicalTrials.gov ID: NCT06835361
What this study is testing
What is Clotrimazole+Lactulose.?
Clotrimazole+Lactulose. is an investigational medicine, being studied as a potential treatment for candidal vulvovaginitis (icd-10 code: b37.3).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Women aged 18 to 60 years.
- Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
- Negative pregnancy test at screening.
- Agreement to use reliable contraception throughout the study and for 30 days after its completion.
- Signed informed consent.
You likely can't join if
- Pregnancy or breastfeeding.
- Diagnosed bacterial vaginosis.
- Chronic inflammatory or atrophic diseases of the female genital organs.
- History of malignant neoplasms.
- Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Minsk, Minsk City, Belarus
- Minsk, Belarus
- Ryazan, Ryazan Oblast, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minsk, Minsk City, Belarus; Minsk, Belarus; Ryazan, Ryazan Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.