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Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications.
This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oteseconazole (VT-1161) 150mg capsule | Experimental | 600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14 |
|
| Fluconazole 150mg capsule / Placebo | Active Comparator | 150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oteseconazole (VT-1161) 150mg capsule | Drug | 600mg administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population | The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense) | 48 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 34 | Tucson | Arizona | 85712 | United States | ||
| 39 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36396498 | Derived | Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available. |
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Of the 251 subjects screened, 32 did not meet eligibility requirements and were not enrolled (i.e., not assigned to a treatment arm for the 2-week induction phase).
After providing consent, 251 subjects were screened and, of those, a total of 219 subjects were randomly assigned to the oteseconazole or fluconazole/placebo group for a 2-week induction phase. During the induction phase, subjects received either oteseconazole or fluconazole. Subjects whose presenting acute VVC episode resolved during the induction phase (a total of 185 subjects) entered a 48-week maintenance phase comprised of an 11-week treatment period and a 37-week follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oteseconazole (VT-1161) | 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. |
| FG001 | Fluconazole / Placebo | 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 2-Week Induction Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2019 | Nov 29, 2021 |
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| Fluconazole 150mg capsule | Drug | 150mg administered every 72 hours in 3 sequential doses starting on Day 1. |
|
| Placebo | Drug | Administered once weekly starting on Day 14. |
|
| Encino |
| California |
| 91436 |
| United States |
| 25 | Los Angeles | California | 90036 | United States |
| 22 | Englewood | Colorado | 80112 | United States |
| 49 | Boca Raton | Florida | 33486 | United States |
| 14 | Gainesville | Florida | 32607 | United States |
| 13 | Leesburg | Florida | 34748 | United States |
| 33 | Loxahatchee Groves | Florida | 33470 | United States |
| 36 | Miami | Florida | 33155 | United States |
| 17 | Savannah | Georgia | 31406 | United States |
| 27 | Idaho Falls | Idaho | 83404 | United States |
| 10 | Nampa | Idaho | 83687 | United States |
| 62 | Chicago | Illinois | 60643 | United States |
| 41 | Fort Wayne | Indiana | 46825 | United States |
| 30 | Marrero | Louisiana | 70072 | United States |
| 50 | Dearborn Heights | Michigan | 48127 | United States |
| 29 | Saginaw | Michigan | 48602 | United States |
| 55 | Traverse City | Michigan | 49686 | United States |
| 32 | Troy | Michigan | 48085 | United States |
| 26 | Kansas City | Missouri | 64111 | United States |
| 42 | New Brunswick | New Jersey | 08901 | United States |
| 47 | Ocean City | New Jersey | 07712 | United States |
| 37 | Charlotte | North Carolina | 28207 | United States |
| 38 | Fayetteville | North Carolina | 28304 | United States |
| 15 | Columbus | Ohio | 43213 | United States |
| 18 | Bluffton | South Carolina | 29910 | United States |
| 48 | Myrtle Beach | South Carolina | 29572 | United States |
| 20 | Bristol | Tennessee | 37620 | United States |
| 21 | Murfreesboro | Tennessee | 37130 | United States |
| 24 | Austin | Texas | 78705 | United States |
| 23 | Fort Worth | Texas | 76104 | United States |
| 63 | Katy | Texas | 77450 | United States |
| 58 | League City | Texas | 77573 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| 48-Week Maintenance Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oteseconazole (VT-1161) | 600mg on Day 1 and 450mg on Day 2, followed by 150mg once weekly for 11 weeks starting on Day 14. |
| BG001 | Fluconazole / Placebo | 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1, followed by placebo once weekly for 11 weeks starting on Day 14. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population | The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense) | Analysis was performed on the ITT population which includes subjects who failed to clear their initial acute VVC episode during the induction phase. The ITT population was defined as all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: treatment, baseline body mass index, baseline age, ethnicity, and visit. The 'percentage of participants' measure represents an average of 10 individual tests using multiple imputation. | Posted | Number | percentage of participants | 48 Weeks |
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Day 1 through Week 50
The safety population was defined as all randomized subjects who received at least 1 dose of investigational product. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. One subject assigned to the oteseconazole (VT-1161) arm was not included in the safety population because she did not receive any investigation product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oteseconazole (Induction Phase) | 600mg oteseconazole on Day 1 and 450mg oteseconazole on Day 2 | 0 | 146 | 0 | 146 | 8 | 146 |
| EG001 | Oteseconazole (Maintenance Phase) | 150mg oteseconazole once weekly for 11 weeks starting on Day 14. | 1 | 123 | 3 | 123 | 35 | 123 |
| EG002 | Fluconazole (Induction Phase) | 150mg fluconazole every 72 hours in 3 sequential doses starting on Day 1 | 0 | 72 | 0 | 72 | 8 | 72 |
| EG003 | Placebo (Maintenance Phase) | Placebo once weekly for 11 weeks starting on Day 14. | 0 | 62 | 1 | 62 | 21 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia viral | Infections and infestations | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Retroperitoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Corona virus infection | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Neither institution nor investigator can disclose information pertaining to study until sponsor issues multi-center publication. If multi-center publication is not issued within 18 months of study completion and database lock at all sites, sponsor has 30 days from receipt to review institution's and/or investigator's communication and can require removal of confidential information other than study data and/or delay release of institution's and/or investigator's communication for 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Administration | Mycovia Pharmaceuticals Inc | 919-467-8539 | adminops@mycovia.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2020 | Nov 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| 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 |
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| ID | Term |
|---|---|
| C000599187 | VT-1161 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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