Stress Urinary Incontinence
Conditions
Brief summary
The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.
Interventions
DRUGGTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
DRUGMatching Placebo
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Sponsors
GTx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods * Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information * 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 * Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of Response, stress incontinence | baseline to 20 weeks | Change from G201002 baseline in the mean number of stress incontinence episodes per day |
| Durability of Response, patient global impression of severity | baseline to 20 weeks | Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction) |
| Durability of Response, patient global impression of improvement | baseline to 20 weeks | Change from G201002 baseline in patient global impression of improvement scale (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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of Response, urge incontinence | baseline to 20 weeks | Change from G201002 baseline in the mean number of urge incontinence episodes per day |
| Durability of Response, total incontinence | baseline to 20 weeks | Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day |
Countries
United States
Outcome results
None listed