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

February 28, 2024 updated by: GTx

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of GTx-024, adverse events
Time Frame: baseline through study completion, an average of 1 year
Change from baseline in incidence of adverse events
baseline through study completion, an average of 1 year
Safety of GTx-024, liver function test
Time Frame: baseline through study completion, an average of 1 year
Change from baseline in liver function test
baseline through study completion, an average of 1 year
Safety of GTx-024, lipid panel
Time Frame: baseline through study completion, an average of 1 year
Change from baseline in lipid panel
baseline through study completion, an average of 1 year
Safety of GTx-024, sex-hormone binding globulin levels
Time Frame: baseline through study completion, an average of 1 year
Change from baseline in sex-hormone binding globulin levels
baseline through study completion, an average of 1 year
Safety of GTx-024, testosterone levels
Time Frame: baseline through study completion, an average of 1 year
Change from baseline in testosterone levels
baseline through study completion, an average of 1 year
Safety of GTx-024, endometrial stripe thickness
Time Frame: baseline through study completion, an average of 1 year
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
Time Frame: baseline through study completion, an average of 1 year
Change from baseline weight
baseline through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of GTx-024, stress incontinence
Time Frame: baseline through study completion, an average of 1 year
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
Time Frame: 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)
baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of improvement
Time Frame: 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)
baseline through study completion, an average of 1 year
Efficacy of GTx-024, urge incontinence
Time Frame: baseline through study completion, an average of 1 year
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
Time Frame: baseline through study completion, an average of 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GTx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Peters, MD, Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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