Clincosm LogoSign in Get a demo

Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

Sponsor
GTx (Industry)
Overall Status
Terminated
CT.gov ID
NCT03508648
Collaborator
(none)
93
Enrollment
46
Locations
3
Arms
3.8
Actual Duration (Months)
2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Actual Study Start Date :
May 28, 2018
Actual Primary Completion Date :
Sep 21, 2018
Actual Study Completion Date :
Sep 21, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Matching Placebo

Subjects previously enrolled in the placebo arm of study G201002.

Drug: Matching Placebo
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Active Comparator: 1 mg GTx-024

Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.

Drug: GTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Other Names:
  • enobosarm

    		•
    Active Comparator: 3 mg GTx-024

    Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.

    Drug: GTx-024
    Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
    Other Names:
  • enobosarm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Durability of Response, stress incontinence [baseline to 20 weeks]

      Change from G201002 baseline in the mean number of stress incontinence episodes per day

    2. Durability of Response, patient global impression of severity [baseline to 20 weeks]

      Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)

    3. Durability of Response, patient global impression of improvement [baseline to 20 weeks]

      Change from G201002 baseline in patient global impression of improvement scale (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)

    Secondary Outcome Measures

    1. Durability of Response, urge incontinence [baseline to 20 weeks]

      Change from G201002 baseline in the mean number of urge incontinence episodes per day

    2. Durability of Response, total incontinence [baseline to 20 weeks]

      Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods

    • Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information

    • 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

    • Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Center of Alabama Homewood Alabama United States 35209
    2 Coastal Clinical Research Inc Mobile Alabama United States 36608
    3 Alaska Clinical Research Center Anchorage Alaska United States 99503
    4 Genitourinary Surgical Consultants Denver Colorado United States 80220
    5 Urology Associates Research Englewood Colorado United States 80113
    6 Women's Health Specialty Care Farmington Connecticut United States 06032
    7 Coastal Connecticut Research, LLC New London Connecticut United States 06320
    8 South Florida Medical Research Aventura Florida United States 33180
    9 Tampa Bay Medical Research Inc Clearwater Florida United States 33761
    10 Midland Florida Clinical Research Center LLC DeLand Florida United States 32720
    11 Medical Research of Florida Miami Florida United States 33186
    12 Clinical Research Center of Florida Pompano Beach Florida United States 33060
    13 Mount Vernon Clinical Research LLC Sandy Springs Georgia United States 30328
    14 Clinical Research Prime Idaho Falls Idaho United States 83221
    15 Idaho Urologic Institue Meridian Idaho United States 83642
    16 First Urology PSC Jeffersonville Indiana United States 47130
    17 Iowa Clinic West Des Moines Iowa United States 50266
    18 DelRicht Clinical Research, LLC New Orleans Louisiana United States 70115
    19 Regional Urology Shreveport Louisiana United States 71106
    20 Chesapeake Urology Associates PA Hanover Maryland United States 21076
    21 Boston Clinical Trials Boston Massachusetts United States 02131
    22 Bay State Clinical Trials Watertown Massachusetts United States 02472
    23 Beyer Research Kalamazoo Michigan United States 49009
    24 William Beaumont Hospital Urology Research Royal Oak Michigan United States 48073
    25 Women's Clinic of Lincoln Lincoln Nebraska United States 68510
    26 Sheldon J Freedman MD Ltd Las Vegas Nevada United States 89144
    27 Premier Urology Group, LL Edison New Jersey United States 08837
    28 Lawrence Obs Gyn clinical Research Lawrenceville New Jersey United States 08648
    29 Delaware Valley Urology Mount Laurel New Jersey United States 08054
    30 Accumed Research Associates Garden City New York United States 11530
    31 Manhattan Medical Research Practice PLLC New York New York United States 10016
    32 Circuit Clinical West Seneca New York United States 14224
    33 American Health Research Inc Charlotte North Carolina United States 28207
    34 Eastern Carolina Women's New Bern North Carolina United States 28562
    35 The Urology Group Cincinnati Ohio United States 45212
    36 Aventiv Research Columbus Ohio United States 43213
    37 Institute for Female Pelvic Medicine Allentown Pennsylvania United States 18103
    38 Urologic Consultants of Southeastern PA LLP Bala-Cynwyd Pennsylvania United States 19004
    39 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    40 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
    41 The Jackson Clinic Jackson Tennessee United States 38305
    42 Elligo - Austin Area OBGYN Austin Texas United States 78758
    43 Urology Clinics of North Texas Dallas Texas United States 75231
    44 Urology San Antonio Research PA San Antonio Texas United States 78229
    45 Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice Layton Utah United States 84041
    46 Seattle Womens: Health, Research, Gynocology Seattle Washington United States 98105

    Sponsors and Collaborators

    • GTx

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GTx
    ClinicalTrials.gov Identifier:
    NCT03508648
    Other Study ID Numbers:
    • G201003
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    Oct 1, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Oct 1, 2018