Trial Outcomes & Findings for GTx-024 as a Treatment for Stress Urinary Incontinence in Women (NCT NCT02658448)
NCT ID: NCT02658448
Last Updated: 2021-02-01
Results Overview
To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-02-01
Participant Flow
Participant milestones
| Measure |
GTx-024 3 mg
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
GTx-024 3 mg
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
GTx-024 as a Treatment for Stress Urinary Incontinence in Women
Baseline characteristics by cohort
| Measure |
GTx-024 3 mg
n=19 Participants
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
Age, Continuous
|
61.4 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
|
Baseline mean number of stress leaks per day
|
5.17 number of leaks per day
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: all patients with at least one post enrollment assessment
To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary
Outcome measures
| Measure |
GTx-024 3 mg
n=18 Participants
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
|
81 percent reduction
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: all patients with at least one post enrollment assessment
To describe the effect of 12 weeks of treatment of GTx-024 on SUI as assessed by 24 hour pad weight test. Mean percent reduction in pad weight
Outcome measures
| Measure |
GTx-024 3 mg
n=18 Participants
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight
|
71 percent
Interval 27.0 to 126.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence.
Outcome measures
| Measure |
GTx-024 3 mg
n=19 Participants
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
Number of Participants With Adverse Events
|
9 Participants
|
Adverse Events
GTx-024 3 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GTx-024 3 mg
n=19 participants at risk
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
|
|---|---|
|
General disorders
headache
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
nausea
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle soreness
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
General disorders
fatigue
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Endocrine disorders
hot flash
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
General disorders
insomnia
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
urinary frequency
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
acne
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Infections and infestations
tooth abscess
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
vaginal itching
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
vaginal bleeding
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Investigations
elevated alanine aminotransferase
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Investigations
low HDL
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Investigations
elevated HDL
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Investigations
low sex hormone binding globulin
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
breast cyst
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
proteinuria
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
ketonuria
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
bilirubinuria
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
hypertension
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
pelvic floor muscle spasm
|
5.3%
1/19 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
urinary tract infection
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Infections and infestations
periodontitis
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Infections and infestations
thrush
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Infections and infestations
cold
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Infections and infestations
flu
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
abdominal muscle soreness
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Investigations
elevated INR
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
cyctocele
|
5.3%
1/19 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place