Stress Urinary Incontinence
Conditions
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.
Interventions
DRUGGTx-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.
Sponsors
GTx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of GTx-024, weight | baseline through study completion, an average of 1 year | Change from baseline weight |
| Safety of GTx-024, liver function test | baseline through study completion, an average of 1 year | Change from baseline in liver function test |
| Safety of GTx-024, lipid panel | baseline through study completion, an average of 1 year | Change from baseline in lipid panel |
| Safety of GTx-024, sex-hormone binding globulin levels | baseline through study completion, an average of 1 year | Change from baseline in sex-hormone binding globulin levels |
| Safety of GTx-024, testosterone levels | baseline through study completion, an average of 1 year | Change from baseline in testosterone levels |
| Safety of GTx-024, endometrial stripe thickness | baseline through study completion, an average of 1 year | Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound |
| Safety of GTx-024, adverse events | baseline through study completion, an average of 1 year | Change from baseline in incidence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of GTx-024, patient global impression of severity | 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) |
| Efficacy of GTx-024, patient global impression of improvement | 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) |
| Efficacy of GTx-024, urge incontinence | baseline through study completion, an average of 1 year | Change from baseline in the mean number of urge incontinence episodes per day |
| Efficacy of GTx-024, total incontinence | baseline through study completion, an average of 1 year | Change from baseline in the mean number of total (stress + urge) incontinence episodes per day |
| Efficacy of GTx-024, stress incontinence | baseline through study completion, an average of 1 year | Change from baseline in the mean number of stress incontinence episodes per day |
Countries
United States
Outcome results
None listed