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Surgical Preceptor for Boston Scientific, Lumenis, Urologix and Medtronics
G201002 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
Each subject must meet all of the following criteria to be enrolled in this study:
- Able to read, understand, and provide written, dated, informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information.
- Female, 18 to 80 years of age, inclusive at screening.
- Undergone spontaneous, medically induced or surgical menopause prior to the start of this study.
- Post-menopausal is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- SUI symptoms for at least 6 months duration
- Predominant SUI (MESA questionnaire) at screening
- 24 hour pad weight >3 grams during screening period
- A minimum of 1 and no more than 15 stress incontinence episodes on any single day AND no fewer than 9 total stress incontinence episodes over 3 days as reported in the 3-day voiding diary, determined during the screening period
- Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin within pre-specified normal range
- Note: Laboratory values falling outside of pre-specified ranges may be retested once at the discretion of the investigator
- Results of the retest must be within pre-specified ranges and must be available prior to the baseline visit
- Positive bladder stress test at the screening visit
- Subject agrees to not start any new treatment (medication or otherwise) during the treatment and follow-up periods, including vaginal rejuvenation, that is know or suspected to affect lower urinary tract function
- Subject agrees to discontinue use of bladder support devices during the screening, treatment, and follow-up periods.
- Subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period
- During screening, subject must provide evidence of having received a mammogram examination within the 6 months prior to screening, or she must agree to receive a mammogram examination during screening
A subject meeting any of the following criteria will be excluded from the study:
- Pelvic floor physical therapy in a clinical setting within 30 days prior to screening
- History of pelvic radiation treatment
- History of urethral diverticula
- History of urethral sling, anterior prolapse repair
- Treatment with urethral bulking agents and/or other SUI procedure or surgery within 6 months prior to the Screening visit
- Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities that, in the investigator’s opinion, may impact the patient’s response
- Vaginal rejuvenation treatment within 6 months prior to Screening visit
- Subject has urinary incontinence of neurogenic etiology
- Subject is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater)
- Chronic hepatitis (i.e., inflammation of the liver which has been ongoing for at least 6 months)
- Hepatic cirrhosis due to, for example, sustained excessive alcohol consumption, hepatitis B virus, hepatitis C virus, or fatty liver disease
- Evidence of active infection with hepatitis B or hepatitis C, as determined by serology
- History of human immunodeficiency virus (HIV infection)
- Subjects taking systemic hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings)
- Subjects with a history of breast or endometrial cancer
- Each subject will be required to have a mammogram during the screening period OR provide evidence that a mammogram has been performed within the 6 months prior to screening.
- Significant cardiac disease history
- For subjects with an intact uterus, > 5 mm endometrial stripe thickness as measured at screening by TVUS
- Clinically confirmed urinary tract infection at the Screening Visit
- Current or past history of any physical condition that in the investigator’s opinion might put the subject at risk or interfere with study results
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