Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

GTx

Status and phase: Withdrawn; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Drug: Matching Placebo; Drug: GTx-024

Study type: Interventional

Funder types: Industry

Identifiers

NCT03508648

G201003

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Matching Placebo

Placebo Comparator group

Description:

Subjects previously enrolled in the placebo arm of study G201002.

Treatment:

Drug: Matching Placebo

1 mg GTx-024

Active Comparator group

Description:

Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.

Treatment:

Drug: GTx-024

3 mg GTx-024

Active Comparator group

Description:

Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.

Treatment:

Drug: GTx-024