Stress Urinary Incontinence
Conditions
Brief summary
The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
Interventions
DRUGGTx-024
GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
Sponsors
GTx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Give voluntary, written and signed, informed consent * Female * Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy * SUI symptoms for at least 6 months duration * Predominant SUI (MESA questionnaire) * 24 hour pad weight \>3 gms at baseline * A minimum of 1 SUI episode per day, in the 3 day diary * 3-15 SUI episodes per day, averaged over 3 days, in the 3 day diary * Serum AST and ALT within normal limits * Total bilirubin within normal limits * Positive Bladder Stress Test during screening * Subject agrees to not start any new treatment (medication or otherwise) that is known to affect lower urinary tract function throughout the treatment and follow up periods * Subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period
Exclusion criteria
* Pelvic floor physical therapy in a clinical setting within 30 days prior to screening * History of pelvic radiation treatment * History of urethral diverticula * History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other SUI procedure or surgery * Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment * Urinary incontinence of neurogenic etilogy * Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater) * Chronic hepatitis * Hepatic cirrhosis * HIV and/or hepatitis A, B, or C * Subjects taking systemic hormone products * Subjects with a history of breast or endometrial cancer * Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline, severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA, uncontrolled hypertension (systolic \> 150 and/or diastolic \> 100 mm Hg) * Subjects with an entry measurement of \> 5 mm endometrial stripe thickness * Clinically confirmed urinary tract infection * Any other condition which per investigators' judgment may increase subject risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight | 12 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 12 weeks | To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | GTx-024 3 mg |
|---|---|
| Age, Continuous | 61.4 years |
| Baseline mean number of stress leaks per day | 5.17 number of leaks per day |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 9 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
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
Time frame: 12 weeks
Population: all patients with at least one post enrollment assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GTx-024 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 |
Secondary
Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight
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
Time frame: 12 weeks
Population: all patients with at least one post enrollment assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GTx-024 3 mg | Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight | 71 percent |
Other Pre-specified
Number of Participants With Adverse Events
To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GTx-024 3 mg | Number of Participants With Adverse Events | 9 Participants |