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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: GTx-024

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Center for Continence and Pelvic Health, University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GTx-024; GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg; Other Names: enobosarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GTx
• Investigators: Principal Investigator: Kenneth M. Peters, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: G201001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO