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

Stress Urinary Incontinence Clinical Trial

Official title:

GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658448
• Other study ID #: G201001
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: January 2021
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• GTx-024
GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg

Locations

Country	Name	City	State
United States	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Penn Center for Continence and Pelvic Health, University of Pennsylvania	Philadelphia	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events	To describe the safety profile of GTx-024 3 mg PO daily in subjects with stress urinary incontinence.	12 weeks
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	12 weeks
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	12 weeks