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Androgen Replacement Therapy

Testosterone Solution for Hypergonadotropic Hypogonadism

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

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.

Eligible Conditions

Hypergonadotropic Hypogonadism
Low Testosterone

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12

Secondary study objectives

Hypogonadism

Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores

Other study objectives

Change From Baseline in Total International Prostate Symptom Score (IPSS)

Side effects data

From 2015 Phase 3 trial • 715 Patients • NCT01816295

Haematocrit increased

Arthralgia

Burning sensation

Application site pain

Nasopharyngitis

Upper respiratory tract infection

Prostatic specific antigen increased

Rash papular

Hypertension

Gastrooesophageal reflux disease

Urinary tract infection

Depression

Skin irritation

Meniscus injury

Electrocardiogram abnormal

Weight decreased

Hyperlipidaemia

Hypertriglyceridaemia

Back pain

Muscle spasms

Headache

Hypoaesthesia

Paraesthesia

Dyspepsia

Haemorrhoids

Nausea

Application site irritation

Axillary pain

Fatigue

Oedema peripheral

Pyrexia

Gastroenteritis viral

Influenza

Pharyngitis

Sinusitis

Anxiety

Insomnia

Nipple pain

Cough

Acne

Dermatitis

Dermatitis contact

Erythema

Pruritus

Rash

Flushing

Neck pain

Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Solution - Double Blind

Testosterone Solution - Double Blind

Testosterone Solution - OLE

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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