Trial Outcomes & Findings for Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms (NCT NCT04278872)
NCT ID: NCT04278872
Last Updated: 2022-01-11
Results Overview
Moderate to severe vasomotor symptoms collected daily by e-diary
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2022-01-11
Participant Flow
Participant milestones
| Measure |
SJX-653
Participants will receive SJX-653
SJX-653: administered orally once daily
|
Placebo
Participants will receive placebo
Placebo: administered orally once daily
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
SJX-653
Participants will receive SJX-653
SJX-653: administered orally once daily
|
Placebo
Participants will receive placebo
Placebo: administered orally once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Study Termination
|
2
|
0
|
Baseline Characteristics
Phase 2 Study of SJX-653 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Baseline characteristics by cohort
| Measure |
SJX-653
n=7 Participants
Participants will receive SJX-653
SJX-653: administered orally once daily
|
Placebo
n=6 Participants
Participants will receive placebo
Placebo: administered orally once daily
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 3.29 • n=39 Participants
|
58.3 years
STANDARD_DEVIATION 4.03 • n=41 Participants
|
57.2 years
STANDARD_DEVIATION 3.67 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Study was terminated early and program discontinued. Raw data (patient-reported outcomes/diary entries) were not processed to obtain primary outcome measures, therefore primary outcome measures could not be analyzed.
Moderate to severe vasomotor symptoms collected daily by e-diary
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 6Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 4Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 4Outcome measures
Outcome data not reported
Adverse Events
SJX-653
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SJX-653
n=7 participants at risk
Participants will receive SJX-653
SJX-653: administered orally once daily
|
Placebo
n=6 participants at risk
Participants will receive placebo
Placebo: administered orally once daily
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 3 • 6 weeks
Treatment-Emergent Adverse Events
|
16.7%
1/6 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/7 • 6 weeks
Treatment-Emergent Adverse Events
|
16.7%
1/6 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 4 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Investigations
ALT increased
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Investigations
AST increased
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Investigations
LDH increased
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Investigations
GLDH increased
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Postmenopausal hemorrhage
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/7 • 6 weeks
Treatment-Emergent Adverse Events
|
16.7%
1/6 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Bacterial vaginosis
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Cystitis
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 2 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Investigations
SARS-Cov-2 test positive
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Renal and urinary disorders
Dysuria
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
|
Reproductive system and breast disorders
Ovarian cyst
|
14.3%
1/7 • Number of events 1 • 6 weeks
Treatment-Emergent Adverse Events
|
0.00%
0/6 • 6 weeks
Treatment-Emergent Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place