Clinical trial NCT03566290: Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of GTx-024, adverse events
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, liver function test
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, lipid panel
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, sex-hormone binding globulin levels
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, testosterone levels
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, endometrial stripe thickness
timeFrame: baseline through study completion, an average of 1 year
measure: Safety of GTx-024, weight
timeFrame: baseline through study completion, an average of 1 year
Secondary outcomes:
measure: Efficacy of GTx-024, stress incontinence
timeFrame: baseline through study completion, an average of 1 year
measure: Efficacy of GTx-024, patient global impression of severity
timeFrame: baseline through study completion, an average of 1 year
measure: Efficacy of GTx-024, patient global impression of improvement
timeFrame: baseline through study completion, an average of 1 year
measure: Efficacy of GTx-024, urge incontinence
timeFrame: baseline through study completion, an average of 1 year
measure: Efficacy of GTx-024, total incontinence
timeFrame: baseline through study completion, an average of 1 year
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Center of Alabama
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Englewood
country: United States
facility: Urology Associates Research
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Aventura
country: United States
facility: So. Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center LLC
state: Florida
city: Miami
country: United States
facility: Medical Research of Florida
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institue
state: Idaho
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Associates PA
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Bay State clinical Trials
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital Urology Research
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon J Freedman MD Ltd
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group, LL
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence Obs Gyn clinical Research
state: New Jersey
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern PA LLP
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Austin
country: United States
facility: Elligo - Austin Area OBGYN
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research PA
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
state: Utah
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Womens: Health, Research, Gynocology
state: Washington
Study officials:
affiliation: Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: