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Selective Androgen Receptor Modulator

Open-Label Extension, 3 mg GTx-024 for Stress Incontinence

Phase 2
Waitlist Available
Led By Kenneth Peters, MD
Research Sponsored by GTx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 1 year
Awards & highlights

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.

Eligible Conditions
  • Stress Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of GTx-024, adverse events
Endometrium
Safety of GTx-024, lipid panel
+4 more
Secondary outcome measures
Efficacy of GTx-024, patient global impression of improvement
Efficacy of GTx-024, patient global impression of severity
Efficacy of GTx-024, stress incontinence
+2 more

Side effects data

From 2014 Phase 3 trial • 321 Patients • NCT01355484
36%
Nausea
34%
Alopecia
29%
Anaemia
21%
Asthenia
18%
Vomiting
17%
Arthralgia
14%
Disease Progression
13%
Dyspnoea
13%
Neutropenia
13%
Fatigue
12%
Peripheral Sensory Neuropathy
11%
Diarrhoea
11%
Constipation
8%
Pain In Extremity
8%
Pyrexia
8%
Myalgia
7%
Decreased Appetite
7%
Cough
6%
Neuropathy Peripheral
5%
Chest Pain
5%
Pneumonia
4%
Haemoptysis
3%
Febrile Neutropenia
1%
Upper Gastrointestinal Haemorrhage
1%
Syncope
1%
Pleural Effusion
1%
Pneumothorax
1%
Dehydration
1%
Hypoglycaemia
1%
Radiation Oesophagitis
1%
Lower Limb Fracture
1%
Metastases To Bone
1%
Hyponatraemia
1%
Hypovolaemia
1%
Jugular Vein Thrombosis
1%
Radiation Pneumonitis
1%
Subdural Haematoma
1%
Condition Aggravated
1%
General Physical Health Deterioration
1%
Non-Cardiac Chest Pain
1%
Respiratory Failure
1%
Granulocytopenia
1%
Urinary Tract Infection
1%
Infectious Pleural Effusion
1%
Respiratory Tract Infection
1%
Viral Infection
1%
Venous Thrombosis
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Cerebral Infarction
1%
Cerebrovascular Accident
1%
Completed Suicide
1%
Renal Failure
1%
Abdominal Operation
1%
Thrombocytopenia
1%
Hydropneumothorax
1%
Pulmonary Embolism
1%
Leukopenia
1%
Dysphagia
1%
Duodenal Ulcer
1%
Cardio-Respiratory Arrest
1%
Open Fracture
1%
Metastases To Central Nervous System
1%
Cardiopulmonary Failure
1%
Neutrophil Count Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
GTx-024
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label Extension, 3 mg GTx-024Experimental Treatment1 Intervention
Eligible subjects from G201002
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enobosarm
Not yet FDA approved

Find a Location

Who is running the clinical trial?

GTxLead Sponsor
19 Previous Clinical Trials
5,139 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorProfessor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
26 Previous Clinical Trials
2,026 Total Patients Enrolled
~0 spots leftby Sep 2025
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