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

Sponsor
GTx (Industry)
Overall Status
Terminated
CT.gov ID
NCT03566290
Collaborator
(none)
129
Enrollment
46
Locations
1
Arm
2.8
Actual Duration (Months)
2.8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2, Open-Label Extension Study to Assess Long-Term Safety and Tolerability of Enobosarm (GTx 024) in Postmenopausal Women With Stress Urinary Incontinence
Actual Study Start Date :
Jun 28, 2018
Actual Primary Completion Date :
Sep 21, 2018
Actual Study Completion Date :
Sep 21, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of GTx-024, adverse events [baseline through study completion, an average of 1 year]

      Change from baseline in incidence of adverse events

    2. Safety of GTx-024, liver function test [baseline through study completion, an average of 1 year]

      Change from baseline in liver function test

    3. Safety of GTx-024, lipid panel [baseline through study completion, an average of 1 year]

      Change from baseline in lipid panel

    4. Safety of GTx-024, sex-hormone binding globulin levels [baseline through study completion, an average of 1 year]

      Change from baseline in sex-hormone binding globulin levels

    5. Safety of GTx-024, testosterone levels [baseline through study completion, an average of 1 year]

      Change from baseline in testosterone levels

    6. Safety of GTx-024, endometrial stripe thickness [baseline through study completion, an average of 1 year]

      Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound

    7. Safety of GTx-024, weight [baseline through study completion, an average of 1 year]

      Change from baseline weight

    Secondary Outcome Measures

    1. Efficacy of GTx-024, stress incontinence [baseline through study completion, an average of 1 year]

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

    2. Efficacy of GTx-024, patient global impression of severity [baseline through study completion, an average of 1 year]

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

    3. Efficacy of GTx-024, patient global impression of improvement [baseline through study completion, an average of 1 year]

      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)

    4. Efficacy of GTx-024, urge incontinence [baseline through study completion, an average of 1 year]

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

    5. Efficacy of GTx-024, total incontinence [baseline through study completion, an average of 1 year]

      Change from 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 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

    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 So. 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 Accumed Research Associates Garden City New York United States 11530
    30 Manhattan Medical Research Practice PLLC New York New York United States 10016
    31 Premier Medical Group Poughkeepsie New York United States 12601
    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 Urologic Consultants of Southeastern PA LLP Bala-Cynwyd Pennsylvania United States 19004
    38 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    39 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
    40 The Jackson Clinic Jackson Tennessee United States 38305
    41 Elligo - Austin Area OBGYN Austin Texas United States 78758
    42 Urology Clinics of North Texas Dallas Texas United States 75231
    43 Urology San Antonio Research PA San Antonio Texas United States 78229
    44 Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice Layton Utah United States 84041
    45 Urology of Virginia Virginia Beach Virginia United States 23462
    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:
    NCT03566290
    Other Study ID Numbers:
    • G201004
    First Posted:
    Jun 25, 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