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Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines.
This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.
In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).
This study is identical to VMT-VT-1161-CL-012 (NCT03561701).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oteseconazole (VT-1161) 150mg capsule | Experimental | Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks |
|
| Placebo capsule | Placebo Comparator | Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oteseconazole (VT-1161) | Drug | Oteseconazole (VT-1161) 150mg capsule |
|
| 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 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. 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) | Maintenance phase (post-randomization through Week 48) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 31123 | Birmingham | Alabama | 35233 | United States | ||
| 31108 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319878 | Derived | Sobel JD, Donders G, Degenhardt T, Person K, Curelop S, Ghannoum M, Brand SR. Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis. NEJM Evid. 2022 Aug;1(8):EVIDoa2100055. doi: 10.1056/EVIDoa2100055. Epub 2022 Jul 26. | |
| 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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A total of 438 subjects were enrolled in a 2-week Induction Phase after providing consent. During the Induction Phase, subjects received 3 sequential 150mg of fluconazole administered 72 hours apart. Subjects whose presenting acute VVC (vulvovaginal candidiasis) episode resolved during the Induction Phase (a total of 326) entered a 48-week Maintenance Phase comprised of a 12-week treatment period and a 36-week follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oteseconazole (VT-1161) | 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks |
| FG001 | Placebo | 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 1, 2019 | Oct 12, 2021 |
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| Placebo | Drug | matching placebo capsule |
|
| San Diego |
| California |
| 92111 |
| United States |
| 31139 | Lauderdale Lakes | Florida | 33319 | United States |
| 31143 | Sarasota | Florida | 34239 | United States |
| 31106 | Wellington | Florida | 33414 | United States |
| 31111 | Norcross | Georgia | 30095 | United States |
| 31146 | Covington | Louisiana | 70433 | United States |
| 31105 | Metairie | Louisiana | 70006 | United States |
| 31107 | Metarie | Louisiana | 70001 | United States |
| 31147 | Fall River | Massachusetts | 02720 | United States |
| 31118 | Las Vegas | Nevada | 89123 | United States |
| 31103 | Las Vegas | Nevada | 89128 | United States |
| 31114 | Lawrenceville | New Jersey | 08648 | United States |
| 31142 | Port Jefferson | New York | 11777 | United States |
| 31127 | West Seneca | New York | 14224 | United States |
| 31132 | Greensboro | North Carolina | 27408 | United States |
| 31116 | Morehead City | North Carolina | 28557 | United States |
| 31144 | Raleigh | North Carolina | 27607 | United States |
| 31145 | Winston-Salem | North Carolina | 27103 | United States |
| 31125 | Franklin | Ohio | 45005 | United States |
| 31134 | Philadelphia | Pennsylvania | 19102 | United States |
| 31120 | Bristol | Tennessee | 37620 | United States |
| 31102 | Houston | Texas | 77054 | United States |
| 31117 | Draper | Utah | 84020 | United States |
| 31113 | Richmond | Virginia | 23225 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oteseconazole (VT-1161) | 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks |
| BG001 | Placebo | 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks |
| 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 |
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| 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 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. 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 included all randomized subjects. Missing values were imputed with multiple imputation using the following auxiliary information: region, treatment, baseline body mass index, baseline age, ethnicity, and visit. | Posted | Number | percentage of subjects | Maintenance phase (post-randomization through Week 48) |
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| Post-Hoc | Extension Study Efficacy Outcome Measure | The primary efficacy outcome measure was the proportion of subjects in the Extension modified Intent-to-Treat (mITT) population with one or more culture verified acute VVC episodes (Baseline of the primary study through Week 96 of the extension study). Extension study was conducted at only in the USA at 70 sites. Eligible subjects were required not to have experienced a recurrent VVC episode upon completion of their Week 48 visit. Subjects received no additional investigational treatment. | Posted | Number | percentage of subjects | Extension (Week 49 - Week 96) |
|
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Day 1 through Week 48
The safety population was defined as all randomized subjects who received at least 1 dose of investigational product, which was not administered until Day 1. Treatment-emergent adverse events were defined as adverse events that occurred after the subject received her initial dose of investigational product. Adverse event data were not collected during the induction phase.
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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 (VT-1161) | 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks | 0 | 217 | 3 | 217 | 129 | 217 |
| EG001 | Placebo | 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks | 0 | 109 | 3 | 109 | 63 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | Systematic Assessment |
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| Tubo-ovarian abscess | Infections and infestations | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal haemmorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Limb traumatic amputation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Cystitis | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Genital herpes | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Vaginal infection | Infections and infestations | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
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| Vulvitis | Infections and infestations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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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 | Jul 25, 2020 | Oct 12, 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 |
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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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| Bulgaria |
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| Canada |
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| Japan |
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| Poland |
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| United Kingdom |
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