Trials / Completed
CompletedNCT06411314
Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Avva Rus, JSC · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories | 1 suppository once daily at bedtime for 6 days |
| DRUG | Lactulose 300 mg vaginal suppositories | 1 suppository once daily at bedtime for 6 days |
| DRUG | Pimafucin® (natamycin) 100 mg vaginal suppositories | 1 suppository once daily at bedtime for 6 days |
Timeline
- Start date
- 2022-12-29
- Primary completion
- 2023-07-26
- Completion
- 2023-09-22
- First posted
- 2024-05-13
- Last updated
- 2024-05-13
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT06411314. Inclusion in this directory is not an endorsement.