Safety and tolerability

Testavan® is a 2% transdermal testosterone gel and is indicated for the treatment of adult male hypogonadism.[1]
Treatment with Testavan® restores testosterone levels to within the normal range and provides sustained improvements in sexual function, QoL and fatigue while demonstrating a favourable safety and tolerability profiles. [1-4]

Testosterone chemical structure

Testavan is well tolerated®

Testavan® offers a well-tolerated safety profile and favorable tolerability profile with low incidence of elevated PSA [1-4]


Favourable skin tolerability profile

The most common adverse event in trials was application site reactions (4%) which lasted up to 9 months. The majority of these were mild to moderate in severity. [1]


Low incidence of elevated PSA

Just 2% of patients had a PSA >0.1 nmol/L (n=7/339), with a mean change from baseline of 0.24 ± 0.67 ng/dL [1]


Low frequency of haematocrit events*

Just 1.5% of patients had a haematocrit >54% (n=5/339). [1]1.2% of patients reported an event of increased haematocrit, and two individuals withdrew from the study due to elevated haematocrit levels. [1]

MedDRA system organ class

Common (>1/100 to <1/10)

General disorders and administration site conditions

Application site reaction (including rash, erythema, pruritus, dermatitis, dryness and skin irritation)


Blood triglycerides increase/ hypertriglyceridemia, PSAincreased, red blood cell count increased, haematocrit increased

Vascular disorders


Uncommon adverse events (> 1/1000 to <1/100) include increased haemoglobin and headaches. [1]
No cases of overdose have been reported in clinical trials. [1]

Commonly reported adverse reactions with Testavan® [1]

The commonly reported adverse reactions from phase 2 and phase 3 clinical trials are listed below and trial length was 9 months. The majority of these reactions were mild to moderate in severity. [1]

Man in his late middle age with arms crossed and looking mildly frustrated


Testavan® is contraindicated in the following cases: [1]

Hypersensitivity to the active substance, propylene glycol or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics.

Known or suspected carcinoma of the breast or the prostate

Testavan® is also not indicated for the treatment in women. [1]


1. Testavan® Summary of Product Characteristics. Available from : . Last accessed : August 2022.
2. Belkoff L et al. Andrologia 2018;50(1):e12801.
3. Arver S et al. Andrology 2018;6(3):396–407.
4. Cunningham G et al. Endocr Pract 2017;23(5):557–565.
QoL = quality of life, PSA = prostate specific antigen.

PROMO_1496 Date of Preparation: August 2022