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Androgen
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Phase 2
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 day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.
Eligible Conditions
- Hypogonadotropic Hypogonadism
- Low Testosterone
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
+3 moreSecondary study objectives
Number of Participants With Adverse Events
Side effects data
From 2009 Phase 3 trial • 155 Patients • NCT007026507%
Application site irritation
5%
Headache
5%
Application site erythema
4%
Nasopharyngitis
4%
Haematocrit increased
3%
Diarrhoea
3%
Vomiting
2%
Paranasal sinus hypersecretion
2%
Hypertension
2%
Pyrexia
2%
Fatigue
2%
Influenza
2%
Upper respiratory tract infection
2%
Arthralgia
2%
Insomnia
1%
Sinus congestion
1%
Erythema
1%
Hyperkeratosis
1%
Haemoglobin increased
1%
Application site warmth
1%
Fungal infection
1%
Rhinitis
1%
Epicondylitis
1%
Blood glucose increased
1%
Prostatic specific antigen increased
1%
Hypercholesterolaemia
1%
Back pain
1%
Musculoskeletal pain
1%
Myalgia
1%
Dizziness
1%
Migraine
1%
Presyncope
1%
Anger
1%
Anxiety
1%
Stress
1%
Cough
1%
Appendicitis
1%
Gastrooesophageal reflux disease
1%
Nausea
1%
Application site oedema
1%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testosterone MD-Lotion
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: 4.5 mL (90 mg) of 2% Testosterone MD-LotionExperimental Treatment1 Intervention
Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments.
Group II: 3 mL (60 mg) of 2% Testosterone MD-LotionExperimental Treatment1 Intervention
Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.
Group III: 3 mL (30 mg) of 1% Testosterone MD-LotionExperimental Treatment1 Intervention
Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.
Group IV: 1.5 mL (30 mg) of 2% Testosterone MD-LotionExperimental Treatment1 Intervention
Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments.
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
2,680 Previous Clinical Trials
3,466,363 Total Patients Enrolled
Study DirectorEli Lilly and Company