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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories | Experimental |
| |
| Lactulose 300 mg vaginal suppositories | Active Comparator |
| |
| Pimafucin® (natamycin) 100 mg vaginal suppositories | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories | Combination Product | 1 suppository once daily at bedtime for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | 24 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State Medical and Dental University | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39979898 | Derived | 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. |
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| Lactulose 300 mg vaginal suppositories | Drug | 1 suppository once daily at bedtime for 6 days |
|
| Pimafucin® (natamycin) 100 mg vaginal suppositories | Drug | 1 suppository once daily at bedtime for 6 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 | 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 | 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) | 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 | 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. | 24 days |
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010866 | Natamycin |
| D007792 | Lactulose |
| D013488 | Suppositories |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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