NCT03508648

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

Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GTx · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	GTx-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.
DRUG	Matching 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.

Timeline

• Start date: 2018-05-28
• Primary completion: 2018-09-21
• Completion: 2018-09-21
• First posted: 2018-04-26
• Last updated: 2023-09-14

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated drug study