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Trial record 2 of 4 for:    enobosarm | Stress Incontinence, Female

Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence (ASTRID)

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ClinicalTrials.gov Identifier: NCT03241342
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
GTx

Brief Summary:
GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. Urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. Pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: GTx 024 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Actual Study Start Date : August 21, 2017
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
Active Comparator: 1 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Drug: GTx 024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
Other Name: Enobosarm

Active Comparator: 3 mg GTx-024
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Drug: GTx 024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
Other Name: Enobosarm

Placebo Comparator: matching placebo
Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
Drug: Placebo
Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.




Primary Outcome Measures :
  1. Change in stress incontinence episodes from baseline to week 12 [ Time Frame: 12 Weeks ]
    Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female, 18 to 80 years of age, inclusive, at screening; having undergone spontaneous, medically induced, or surgical menopause prior to the start of the study
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • SUI symptoms of at least 6 months duration
  • Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.
  • 24-Hour pad weight > 3 g during the screening period
  • A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period
  • Positive bladder stress test conducted during the Screening Visit

Key Exclusion Criteria:

  • History of pelvic radiation treatment
  • History of urethral diverticula
  • History of urethral sling or anterior prolapse repair
  • Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit
  • Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities
  • Urinary incontinence of neurogenic etiology
  • Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)
  • Chronic hepatitis
  • Hepatic cirrhosis
  • Evidence of active infection with hepatitis B or hepatitis C
  • History of human immunodeficiency virus (HIV) infection
  • Subjects with a history of breast or endometrial cancer

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): NCT03241342


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Sponsors and Collaborators
GTx
Investigators
Principal Investigator: Kenneth M Peters, MD Oakland University, William Beaumont School of Medicine

Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT03241342     History of Changes
Other Study ID Numbers: G201002
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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
Urinary Incontinence, Stress
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders