GTx-024 as a Treatment for Stress Urinary Incontinence in Women

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
GTx-024 3 mg	GTx-024	GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (3): Penn Center for Continence and Pelvic Health, University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Urologic Consultants of Southeastern Pennsylvania
🇺🇸
Bala-Cynwyd, Pennsylvania, United States