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

NCT03508648 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • GTx

    lead INDUSTRY

Principal Investigators

  • Kenneth Peters, MD · Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2018-09-21
Completion
2018-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508648 on ClinicalTrials.gov