A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)
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| ClinicalTrials.gov Identifier: NCT03561701 |
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Recruitment Status :
Completed
First Posted : June 19, 2018
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
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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 antifungal 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-011.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Vulvovaginal Candidiasis | Drug: Oteseconazole (VT-1161) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 425 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis |
| Actual Study Start Date : | August 23, 2018 |
| Actual Primary Completion Date : | October 13, 2020 |
| Actual Study Completion Date : | August 3, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Oteseconazole (VT-1161) 150mg capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
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Drug: Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule |
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Placebo Comparator: Placebo capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
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Drug: Placebo
matching placebo capsule |
- 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. [ Time Frame: Maintenance phase (post-randomization through Week 48) ]
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 3 or more episodes of acute VVC in the past 12 months
- Positive KOH or Gram stain test
- Total vulvovaginal signs and symptoms score of ≥3 at screening visit
- Total vulvovaginal signs and symptoms score of <3 at baseline visit
- Must be able to swallow pills
Key Exclusion Criteria:
- Presence or a history of another vaginal or vulvar condition(s)
- Evidence of major organ system disease
- History of cervical cancer
- Poorly controlled diabetes mellitus
- Pregnant
- Recent use of topical or systemic antifungal or antibacterial drugs
- Recent use of immunosuppressive or systemic corticosteroid therapies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561701
| United States, Arizona | |
| 31215 | |
| Phoenix, Arizona, United States, 85032 | |
| United States, Arkansas | |
| 31227 | |
| Little Rock, Arkansas, United States, 72212 | |
| United States, California | |
| 31217 | |
| Los Angeles, California, United States, 90057 | |
| United States, Connecticut | |
| 31240 | |
| Hartford, Connecticut, United States, 06105 | |
| United States, Florida | |
| 31204 | |
| Homestead, Florida, United States, 33030 | |
| 31233 | |
| North Bay Village, Florida, United States, 33141 | |
| United States, Kansas | |
| 31255 | |
| Wichita, Kansas, United States, 67226 | |
| United States, Maryland | |
| 31245 | |
| Hagerstown, Maryland, United States, 21740 | |
| United States, North Carolina | |
| 31223 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| 31244 | |
| Columbus, Ohio, United States, 43213 | |
| 31229 | |
| Columbus, Ohio, United States, 43231 | |
| 31222 | |
| Englewood, Ohio, United States, 45322 | |
| United States, Tennessee | |
| 31218 | |
| Jackson, Tennessee, United States, 38305 | |
| United States, Texas | |
| 31232 | |
| Frisco, Texas, United States, 75035 | |
Documents provided by Mycovia Pharmaceuticals Inc.:
| Responsible Party: | Mycovia Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03561701 |
| Other Study ID Numbers: |
VMT-VT-1161-CL-012 |
| First Posted: | June 19, 2018 Key Record Dates |
| Results First Posted: | December 20, 2021 |
| Last Update Posted: | December 20, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Candidiasis Candidiasis, Vulvovaginal Recurrence Disease Attributes Pathologic Processes Mycoses Bacterial Infections and Mycoses Infections Vulvovaginitis |
Vaginitis Vaginal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Vulvitis Vulvar Diseases Genital Diseases |