Trial Outcomes & Findings for A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (NCT NCT03562156)

NCT ID: NCT03562156

Last Updated: 2026-02-17

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 438 participants
• Primary outcome timeframe: Maintenance phase (post-randomization through Week 48)
• Results posted on: 2026-02-17

Participant Flow

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.

Participant milestones

Measure	Oteseconazole (VT-1161) 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Overall Study STARTED	217	109
Overall Study COMPLETED	182	91
Overall Study NOT COMPLETED	35	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Baseline characteristics by cohort

Measure	Oteseconazole (VT-1161) n=217 Participants 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=109 Participants 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Total n=326 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 10.3 • n=25 Participants	34 years STANDARD_DEVIATION 9.9 • n=20 Participants	34 years STANDARD_DEVIATION 10.2 • n=45 Participants
Sex: Female, Male Female	217 Participants n=25 Participants	109 Participants n=20 Participants	326 Participants n=45 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=25 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants
Race (NIH/OMB) Asian	33 Participants n=25 Participants	12 Participants n=20 Participants	45 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	26 Participants n=25 Participants	17 Participants n=20 Participants	43 Participants n=45 Participants
Race (NIH/OMB) White	156 Participants n=25 Participants	80 Participants n=20 Participants	236 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants
Region of Enrollment United States	85 participants n=25 Participants	39 participants n=20 Participants	124 participants n=45 Participants
Region of Enrollment Bulgaria	50 participants n=25 Participants	23 participants n=20 Participants	73 participants n=45 Participants
Region of Enrollment Canada	8 participants n=25 Participants	8 participants n=20 Participants	16 participants n=45 Participants
Region of Enrollment Japan	32 participants n=25 Participants	12 participants n=20 Participants	44 participants n=45 Participants
Region of Enrollment Poland	33 participants n=25 Participants	24 participants n=20 Participants	57 participants n=45 Participants
Region of Enrollment United Kingdom	9 participants n=25 Participants	3 participants n=20 Participants	12 participants n=45 Participants

PRIMARY outcome

Timeframe: Maintenance phase (post-randomization through Week 48)

Population: 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.

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)

Outcome measures

Measure	Oteseconazole (VT-1161) n=217 Participants 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=109 Participants 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
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	6.7 percentage of subjects	42.8 percentage of subjects

POST_HOC outcome

Timeframe: Extension (Week 49 - Week 96)

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.

Outcome measures

Measure	Oteseconazole (VT-1161) n=34 Participants 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=9 Participants 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Extension Study Efficacy Outcome Measure	14.8 percentage of subjects	73.1 percentage of subjects

Adverse Events

Oteseconazole (VT-1161)

Serious events: 3 serious events

Other events: 129 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oteseconazole (VT-1161) n=217 participants at risk 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=109 participants at risk 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Infections and infestations Appendicitis	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 1 • 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.
Infections and infestations Bronchitis	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 1 • 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.
Infections and infestations Pneumonia	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 1 • 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.
Infections and infestations Postoperative wound infection	0.46% 1/217 • Number of events 1 • 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.	0.00% 0/109 • 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.
Infections and infestations Tubo-ovarian abscess	0.46% 1/217 • Number of events 1 • 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.	0.00% 0/109 • 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.
Reproductive system and breast disorders Endometriosis	0.46% 1/217 • Number of events 1 • 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.	0.00% 0/109 • 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.
Reproductive system and breast disorders Vaginal haemmorrhage	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 1 • 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.
Injury, poisoning and procedural complications Limb traumatic amputation	0.46% 1/217 • Number of events 1 • 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.	0.00% 0/109 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/217 • 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.	0.92% 1/109 • Number of events 2 • 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.

Other adverse events

Measure	Oteseconazole (VT-1161) n=217 participants at risk 1 oteseconazole 150mg capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks	Placebo n=109 participants at risk 1 placebo capsule once daily for 7 days starting at Day 1, then once weekly for 11 weeks
Infections and infestations Nasopharyngitis	12.0% 26/217 • Number of events 37 • 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.	6.4% 7/109 • Number of events 10 • 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.
Infections and infestations Bacterial vaginosis	6.5% 14/217 • Number of events 19 • 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.	10.1% 11/109 • Number of events 15 • 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.
Infections and infestations Urinary tract infection	5.5% 12/217 • Number of events 14 • 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.	6.4% 7/109 • Number of events 9 • 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.
Infections and infestations Upper respiratory tract infection	4.1% 9/217 • Number of events 9 • 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.	6.4% 7/109 • Number of events 7 • 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.
Infections and infestations Sinusitis	5.5% 12/217 • Number of events 13 • 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.	2.8% 3/109 • Number of events 3 • 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.
Infections and infestations Cystitis	1.8% 4/217 • Number of events 6 • 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.	7.3% 8/109 • Number of events 13 • 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.
Infections and infestations Influenza	3.2% 7/217 • Number of events 7 • 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.	0.92% 1/109 • Number of events 1 • 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.
Infections and infestations Genital herpes	3.2% 7/217 • Number of events 8 • 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.	0.00% 0/109 • 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.
Infections and infestations Bronchitis	1.8% 4/217 • Number of events 6 • 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.	1.8% 2/109 • Number of events 2 • 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.
Infections and infestations Chlamydial infection	1.8% 4/217 • Number of events 5 • 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.	1.8% 2/109 • Number of events 2 • 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.
Infections and infestations Pharyngitis	2.8% 6/217 • Number of events 6 • 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.	0.00% 0/109 • 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.
Infections and infestations Vaginal infection	0.46% 1/217 • Number of events 1 • 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.	1.8% 2/109 • Number of events 3 • 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.
Infections and infestations Vulvovaginal candidiasis	0.46% 1/217 • Number of events 2 • 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.	1.8% 2/109 • Number of events 2 • 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.
Infections and infestations Vulvitis	0.00% 0/217 • 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.	1.8% 2/109 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	3.7% 8/217 • Number of events 10 • 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.	2.8% 3/109 • Number of events 3 • 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.
Gastrointestinal disorders Diarrhoea	3.7% 8/217 • Number of events 8 • 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.	1.8% 2/109 • Number of events 2 • 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.
Gastrointestinal disorders Abdominal pain	2.3% 5/217 • Number of events 6 • 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.	2.8% 3/109 • Number of events 4 • 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.
Gastrointestinal disorders Abdominal pain lower	1.8% 4/217 • Number of events 4 • 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.	0.92% 1/109 • Number of events 1 • 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.
Gastrointestinal disorders Constipation	0.92% 2/217 • Number of events 2 • 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.	1.8% 2/109 • Number of events 2 • 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.
Reproductive system and breast disorders Vulvovaginal pruritus	3.2% 7/217 • Number of events 7 • 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.	1.8% 2/109 • Number of events 4 • 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.
Reproductive system and breast disorders Metrorrhagia	2.3% 5/217 • Number of events 7 • 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.	2.8% 3/109 • Number of events 3 • 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.
Reproductive system and breast disorders Menorrhagia	1.8% 4/217 • Number of events 4 • 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.	0.92% 1/109 • Number of events 1 • 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.
Reproductive system and breast disorders Pelvic pain	0.92% 2/217 • Number of events 2 • 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.	1.8% 2/109 • Number of events 2 • 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.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/217 • 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.	3.7% 4/109 • Number of events 5 • 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.
Nervous system disorders Headache	3.7% 8/217 • Number of events 8 • 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.	7.3% 8/109 • Number of events 10 • 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.
Skin and subcutaneous tissue disorders Acne	2.3% 5/217 • Number of events 5 • 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.	0.92% 1/109 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Urticaria	1.8% 4/217 • Number of events 5 • 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.	0.92% 1/109 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/217 • 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.	1.8% 2/109 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Back pain	1.4% 3/217 • Number of events 3 • 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.	4.6% 5/109 • Number of events 6 • 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.
Investigations Blood creatine phosphokinase increased	3.2% 7/217 • Number of events 8 • 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.	2.8% 3/109 • Number of events 3 • 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.
General disorders Pyrexia	2.3% 5/217 • Number of events 5 • 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.	3.7% 4/109 • Number of events 4 • 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.
Injury, poisoning and procedural complications Procedural pain	0.92% 2/217 • Number of events 2 • 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.	1.8% 2/109 • Number of events 2 • 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.
Psychiatric disorders Insomnia	1.8% 4/217 • Number of events 4 • 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.	0.92% 1/109 • Number of events 1 • 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.

Additional Information

Clinical Trial Administration

Mycovia Pharmaceuticals Inc

Phone: 919-467-8539

Email: adminops@mycovia.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER