Back to resultsGTx-024 as a Treatment for Stress Urinary Incontinence in Women
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GTx-024
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- William Beaumont Hospital
- Urologic Consultants of Southeastern Pennsylvania
- Penn Center for Continence and Pelvic Health, University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GTx-024 3 mg
Arm Description
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658448
Brief Title
GTx-024 as a Treatment for Stress Urinary Incontinence in Women
Official Title
GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GTx-024 3 mg
Arm Type
Experimental
Arm Description
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
GTx-024
Other Intervention Name(s)
enobosarm
Intervention Description
GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
Primary Outcome Measure Information:
Title
The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
Description
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
Secondary Outcome Measure Information:
Title
Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Description
To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M. Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Penn Center for Continence and Pelvic Health, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GTx-024 as a Treatment for Stress Urinary Incontinence in Women
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