Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence

Phase 2, Open-Label Extension Study to Assess Long-Term Safety and Tolerability of Enobosarm (GTx 024) in Postmenopausal Women With Stress Urinary Incontinence

This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Center of Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research Inc
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Clinical Research Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Genitourinary Surgical Consultants
    • Englewood, Colorado, United States, 80113
      • Urology Associates Research
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Women's Health Specialty Care
    • New London, Connecticut, United States, 06320
      • Coastal Connecticut Research, LLC
  • Florida
    • Aventura, Florida, United States, 33180
      • So. Florida Medical Research
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research Inc
    • DeLand, Florida, United States, 32720
      • Midland Florida clinical Research Center LLC
    • Miami, Florida, United States, 33186
      • Medical Research of Florida
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83221
      • Clinical Research Prime
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institue
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology PSC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Clinical Research, LLC
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Associates PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital Urology Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Sheldon J Freedman MD Ltd
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group, LL
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Obs Gyn clinical Research
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice PLLC
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group
    • West Seneca, New York, United States, 14224
      • Circuit Clinical
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research Inc
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern PA LLP
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Austin, Texas, United States, 78758
      • Elligo - Austin Area OBGYN
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research PA
  • Utah
    • Layton, Utah, United States, 84041
      • Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Womens: Health, Research, Gynocology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Be an eligible subject from G201002, where an eligible subject is defined as:

  1. one of the first 225 subjects who were randomly assigned to the placebo group in G201002 and who have completed the required treatment and durability periods of that study, or;
  2. any subject from 226 onwards, who was randomly assigned to any treatment group and who completed the required treatment and follow-up periods of that study
• Be able to read, understand, and provide written, dated, informed consent prior to enrollment in the current study and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information

• Provide written consent to participate in the study within the following timeframes:

  1. for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects who consent to participate in G201003 will be allowed to discontinue from that study and consent to this study upon unblinding of G201002)
  2. for G201002 Subjects 226-493, within 30 days of completing both the treatment and follow-up periods of G201002
• Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study

Exclusion Criteria:

• Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
• Subject is currently taking systemic sex-hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings)
• Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any history of breast or endometrial cancer

• Has a known history or current episode of:

  1. New York Heart Association Stage ≥ 2 hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) at screening and/or baseline. Subjects with hypertension that has been treated and controlled with medication for ≥ 2 weeks prior to screening are eligible for participation
  2. Recent myocardial infarction or arterial or venous thromboembolic event (within 1 year) or a history of more than 1 myocardial infarction or arterial or venous thromboembolic event
  3. Cardiac-related syncopal event within the past year
  4. Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor
  5. Congestive heart failure of Stage > 2 according to New York Heart Association criteria
  6. Angina pectoris
• Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk, impact the absorption of the study drug, or interfere with interpretation of study

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: Open-Label Extension, 3 mg GTx-024; Eligible subjects from G201002	Drug: GTx-024; Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.; Other Names: enobosarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of GTx-024, adverse events	Change from baseline in incidence of adverse events	baseline through study completion, an average of 1 year
Safety of GTx-024, liver function test	Change from baseline in liver function test	baseline through study completion, an average of 1 year
Safety of GTx-024, lipid panel	Change from baseline in lipid panel	baseline through study completion, an average of 1 year
Safety of GTx-024, sex-hormone binding globulin levels	Change from baseline in sex-hormone binding globulin levels	baseline through study completion, an average of 1 year
Safety of GTx-024, testosterone levels	Change from baseline in testosterone levels	baseline through study completion, an average of 1 year
Safety of GTx-024, endometrial stripe thickness	Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound	baseline through study completion, an average of 1 year
Safety of GTx-024, weight	Change from baseline weight	baseline through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of GTx-024, stress incontinence	Change from baseline in the mean number of stress incontinence episodes per day	baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of severity	Change in patient global impression of severity (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)	baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of improvement	Change in patient global impression of improvement (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)	baseline through study completion, an average of 1 year
Efficacy of GTx-024, urge incontinence	Change from baseline in the mean number of urge incontinence episodes per day	baseline through study completion, an average of 1 year
Efficacy of GTx-024, total incontinence	Change from baseline in the mean number of total (stress + urge) incontinence episodes per day	baseline through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: GTx
• Investigators: Principal Investigator: Kenneth Peters, MD, Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: G201004

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No