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

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ClinicalTrials.gov Identifier: NCT03566290
Recruitment Status : Terminated (Lack of efficacy)
First Posted : June 25, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
GTx

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
Stress Urinary Incontinence Drug: GTx-024 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
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 : June 28, 2018
Actual Primary Completion Date : September 21, 2018
Actual Study Completion Date : September 21, 2018

Resource links provided by the National Library of Medicine


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 Name: enobosarm




Primary Outcome Measures :
  1. 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

  2. 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

  3. Safety of GTx-024, lipid panel [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline through study completion, an average of 1 year ]
    Change from baseline in testosterone levels

  6. 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

  7. Safety of GTx-024, weight [ Time Frame: baseline through study completion, an average of 1 year ]
    Change from baseline weight


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566290


  Show 46 Study Locations
Sponsors and Collaborators
GTx
Investigators
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Principal Investigator: Kenneth Peters, MD Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

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Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT03566290     History of Changes
Other Study ID Numbers: G201004
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders