Trial Outcomes & Findings for A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis (NCT NCT02418845)
NCT ID: NCT02418845
Last Updated: 2021-10-15
Results Overview
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
189 participants
Primary outcome timeframe
Study Days 21-30 (End of Study (EOS))
Results posted on
2021-10-15
Participant Flow
Female post-menarchal participants age 12 and older, inclusive, with a clinical diagnosis of bacterial vaginosis were recruited and enrolled in 21 investigative medical sites throughout the US. Recruitment/enrollment took place between May 4, 2015 and Sep 24, 2015.
Participant milestones
| Measure |
SYM-1219
2 grams administered orally as a single dose
SYM-1219
|
Placebo
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
64
|
|
Overall Study
COMPLETED
|
109
|
52
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
| Measure |
SYM-1219
2 grams administered orally as a single dose
SYM-1219
|
Placebo
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Physician Decision
|
5
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
SYM-1219
n=125 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=64 Participants
Administered orally as a single dose
Placebo
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
64 participants
n=7 Participants
|
189 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Days 21-30 (End of Study (EOS))Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Outcome measures
| Measure |
SYM-1219
n=107 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=57 Participants
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Clinical Outcome Responder Rate
Clinical Outcome Responder
|
57 Participants
|
11 Participants
|
|
Clinical Outcome Responder Rate
Non-Responder
|
50 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Study Days 7-14 (interim)Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Outcome measures
| Measure |
SYM-1219
n=107 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=57 Participants
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Clinical Outcome Responder Rate (Interim Visit Only)
Clinical Outcome Responder
|
62 Participants
|
14 Participants
|
|
Clinical Outcome Responder Rate (Interim Visit Only)
Non-Responder
|
45 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
Outcome measures
| Measure |
SYM-1219
n=107 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=57 Participants
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Gram Stain Slide Nugent Score
Study days 7-14 (interim) · Nugent Score 0-3
|
49 Participants
|
2 Participants
|
|
Gram Stain Slide Nugent Score
Study days 7-14 (interim) · Nugent Score 4 or greater
|
58 Participants
|
55 Participants
|
|
Gram Stain Slide Nugent Score
Study days 21-30 (EOS) · Nugent Score 0-3
|
47 Participants
|
3 Participants
|
|
Gram Stain Slide Nugent Score
Study days 21-30 (EOS) · Nugent Score 4 or greater
|
60 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Study days 7-14 (interim) & study days 21-30 (EOS)Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)
Outcome measures
| Measure |
SYM-1219
n=107 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=57 Participants
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Therapeutic Outcome Responder Rate
Study days 21-30 (EOS) · Non-Responder
|
70 Participants
|
55 Participants
|
|
Therapeutic Outcome Responder Rate
Study days 7-14 (interim) · Therapeutic Outcome Responder
|
37 Participants
|
2 Participants
|
|
Therapeutic Outcome Responder Rate
Study days 7-14 (interim) · Non-Responder
|
70 Participants
|
55 Participants
|
|
Therapeutic Outcome Responder Rate
Study days 21-30 (EOS) · Therapeutic Outcome Responder
|
37 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Study days 21-30 End of Study (EOS)Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Outcome measures
| Measure |
SYM-1219
n=107 Participants
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=57 Participants
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Investigator's Clinical Assessment
Additional BV treatment needed
|
32 Participants
|
38 Participants
|
|
Investigator's Clinical Assessment
No additional treatment needed
|
68 Participants
|
16 Participants
|
|
Investigator's Clinical Assessment
Missing
|
7 Participants
|
3 Participants
|
Adverse Events
SYM-1219
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYM-1219
n=125 participants at risk
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=64 participants at risk
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Nervous system disorders
Syncope
|
0.80%
1/125 • Number of events 1
|
0.00%
0/64
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.80%
1/125 • Number of events 1
|
0.00%
0/64
|
Other adverse events
| Measure |
SYM-1219
n=125 participants at risk
2 grams administered orally as a single dose
SYM-1219
|
Placebo
n=64 participants at risk
Administered orally as a single dose
Placebo
|
|---|---|---|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.2%
9/125
|
3.1%
2/64
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.4%
8/125
|
1.6%
1/64
|
|
Infections and infestations
Bronchitis
|
0.80%
1/125
|
0.00%
0/64
|
|
Infections and infestations
Folliculitis
|
0.80%
1/125
|
0.00%
0/64
|
|
Infections and infestations
Oral candidiasis
|
0.80%
1/125
|
0.00%
0/64
|
|
Infections and infestations
Subcutaneous abcess
|
0.80%
1/125
|
0.00%
0/64
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125
|
3.1%
2/64
|
|
Gastrointestinal disorders
Nausea
|
4.8%
6/125
|
1.6%
1/64
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
5/125
|
1.6%
1/64
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
4/125
|
3.1%
2/64
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
3/125
|
0.00%
0/64
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/125
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dry mouth
|
0.80%
1/125
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dyspepsia
|
0.80%
1/125
|
0.00%
0/64
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.80%
1/125
|
0.00%
0/64
|
|
Gastrointestinal disorders
Toothache
|
0.80%
1/125
|
0.00%
0/64
|
|
Nervous system disorders
Headache
|
4.8%
6/125
|
3.1%
2/64
|
|
Nervous system disorders
Dizziness
|
1.6%
2/125
|
0.00%
0/64
|
|
Nervous system disorders
Syncope
|
0.80%
1/125
|
0.00%
0/64
|
|
Nervous system disorders
Dysgeusia
|
0.80%
1/125
|
0.00%
0/64
|
|
Nervous system disorders
Somnolence
|
0.80%
1/125
|
0.00%
0/64
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
2.4%
3/125
|
3.1%
2/64
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.6%
2/125
|
0.00%
0/64
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.80%
1/125
|
0.00%
0/64
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.80%
1/125
|
0.00%
0/64
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.80%
1/125
|
0.00%
0/64
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/125
|
1.6%
1/64
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/125
|
3.1%
2/64
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
2/125
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.80%
1/125
|
0.00%
0/64
|
|
General disorders
Fatigue
|
0.80%
1/125
|
0.00%
0/64
|
|
General disorders
Pyrexia
|
0.80%
1/125
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
1/125
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.80%
1/125
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/125
|
1.6%
1/64
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
1/125
|
0.00%
0/64
|
|
Psychiatric disorders
Anxiety
|
0.80%
1/125
|
0.00%
0/64
|
|
Renal and urinary disorders
Chromaturia
|
0.80%
1/125
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.80%
1/125
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.80%
1/125
|
0.00%
0/64
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/125
|
1.6%
1/64
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI submits complete copy of publication material to sponsor at least 60 days prior to submission implementing all reasonable sponsor comments. If sponsor determines that proposed publication contains disclosure of intellectual property for which sponsor is seeking patent protection, PI shall delay submission 60 days from sponsor notice so sponsor may file patent application covering intellectual property. PI shall have no further rights to publish sponsor confidential information.
- Publication restrictions are in place
Restriction type: OTHER