Bioequivalence study comparing AndroForte 5 (Registered Trademark (R)) and Testogel (R) 1%

Phase 2

Completed

• Conditions: Testosterone replacement therapy; Hypogonadism; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12610000834055
• Lead Sponsor: awley Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Established androgen deficiency (primary or secondary) (including newly diagnosed persons) requiring androgen replacement therapy as determined by current Pharmaceutical Benefit Scheme (PBS) guidelines (laboratory results demonstrating that Australian guidelines have been met must be available for review)
Or
Established androgen deficiency (primary or secondary) and currently receiving androgen replacement therapy (at an equivalent dose as outlined in this protocol) and willing to withdraw from current androgen replacement therapy and observe the necessary washout period prior to entering the study as outlined below:

- 7 days for transdermal testosterone or oral testosterone undecanoate
- 6-12 weeks for intramuscular injections of testosterone esters
- 6 months since last dose for subcutaneous testosterone pellets or testosterone undecanoate

Exclusion Criteria

* Untreated obstructive sleep apnoea as determined by the Berlin Sleep Apnoea questionnaire

* Clinically significant non-malignant disease including, active clinically significant infection (requiring systemic antibiotics), cerebrovascular event or transient ischemic attack within 12 months prior to randomisation or major surgery within 3 months of randomisation

* Active cardiac disease defined as one or more of the following
- New York Heart Association functional classification of heart failure of greater than or equal to 2 or symptomatic angina
- Uncontrolled arrhythmias, or arrhythmias deemed clinically significant by the investigator
- Myocardial infarction, cardiac stenting or angioplasty in past 6 months

* Prior history of prostate cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Cancer(s) treated with curative intent (including non-melanoma skin cancer) are eligible if disease-free for at least 2 years.

* Any form of respiratory failure requiring oxygen supplementation

* Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior androgen replacement therapy that would, in the investigators’ judgment, make the participant inappropriate for this study

* Receipt of therapy with another investigational drug within 4 weeks of Day 1 or current enrolment in another clinical trial

* Current smoker or past smoker who has ceased smoking within the past year

* Elevated blood pressure (greater than or equal to 140/90mmHg) at screening or a diagnosis of hypertension unless on stable therapy for at least 3 months and currently normotensive

* History of mental illness (requiring ongoing psychotropic medications)

* Active substance abuse

* Known to be human immunodeficiency virus (HIV) or hepatitis B surface antigen positive

* Planned elective surgery within 1 month of randomisation or during the study period

* Generalised skin disease on the abdomen that may be affected by or affect testosterone absorption at the site of transdermal absorption – e.g. psoriasis

* Body Mass Index (BMI) of less than 18 kg/m2 or more than 35 kg/m2 as either extreme may result in hypogonadism responsive to normalisation of weight

* Currently on medications, herbal remedies or vitamins/juices (e.g. grapefruit juice) known to
- Be strong inducers/ inhibitors of Cytochrome 3A4 (CYP 3A4)
- Affect the production (e.g. opiates, gonadotropin releasing hormone (GnRH) agonists) or action (e.g. spironolactone) of androgens
- Affect the production of SHBG (e.g. thyroxine, insulin, growth hormone, antiepileptics), unless the dose has been stable for at least 3 months and will remain so.

* Dementia or altered cognitive function that would interfere with the participant’s safety or compliance to the study procedures

* Use of topical salves or topical steroids to abdomen within past 7 days

* Participants unwilling to adhere to the guidelines in regard to intimate contact post application

* Known allergy to almonds

* Participants experiencing severe voiding symptoms as identified on the International Prostate Symptom Score (IPSS) questionnaire

* Men who are able to father a child who are unwilling to use an acceptable method of contraception during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess Pharmacokinetic (PK) variables: Area under the curve (AUC), Average concentration (Cavg), Maximum plasma concentration (Cmax), Time to maximum plasma concentration (Tmax), % Fluctuation (with and without baseline correction) for AndroForte 5 and Testogel 1% on Day 1 and Day 30 by measuring serum testosterone & dihydrotestosterone.[PK serial sampling will be performed at -15 , -5, 0 min prior and 2, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post administration on Day 1 and 30 of Period I and II of each treatment]