Your session is about to expire
← Back to Search
Androgen Replacement Therapy
Testosterone Solution for Low Testosterone
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
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, week 12, week 36
Awards & highlights
Study Summary
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12
Secondary outcome measures
Hypogonadism
Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
Other outcome measures
Change From Baseline in Total International Prostate Symptom Score (IPSS)
Side effects data
From 2015 Phase 3 trial • 715 Patients • NCT018162953%
Haematocrit increased
2%
Application site pain
2%
Burning sensation
2%
Nasopharyngitis
2%
Arthralgia
2%
Upper respiratory tract infection
1%
Weight decreased
1%
Paraesthesia
1%
Axillary pain
1%
Nausea
1%
Gastrooesophageal reflux disease
1%
Pyrexia
1%
Application site irritation
1%
Oedema peripheral
1%
Electrocardiogram abnormal
1%
Pharyngitis
1%
Hypoaesthesia
1%
Sinusitis
1%
Prostatic specific antigen increased
1%
Headache
1%
Back pain
1%
Muscle spasms
1%
Insomnia
1%
Acne
1%
Depression
1%
Pruritus
1%
Nipple pain
1%
Dermatitis
1%
Cough
1%
Erythema
1%
Rash papular
1%
Flushing
1%
Haemorrhoids
1%
Fatigue
1%
Influenza
1%
Meniscus injury
1%
Anxiety
1%
Dermatitis contact
1%
Hypertension
1%
Urinary tract infection
1%
Hyperlipidaemia
1%
Hypertriglyceridaemia
1%
Gastroenteritis viral
1%
Rash
1%
Skin irritation
1%
Dyspepsia
1%
Neck pain
1%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Solution - Double Blind
Testosterone Solution - Double Blind
Testosterone Solution - OLE
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Testosterone SolutionExperimental Treatment1 Intervention
Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.
Group II: Placebo SolutionPlacebo Group1 Intervention
Placebo Solution applied topically once daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,622 Previous Clinical Trials
3,216,060 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,183 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger