Men aged > 18 years old with primary or secondary hypogonadism. Only patients meeting the inclusion criteria will be enrolled in this study. MedDRA version: 7.1 Level: PT Classification code 10021011
Conditions
Interventions
Trade Name: PANTESTONE
Product Name: PANTESTONE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Testosterone undecanoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Men aged > 18 years with known primary or secondary hypogonadism previously treated or not with androgens ? Serum TT level lower or equal to 2.5 ng/mL (after androgen washout for previously treated patients) ? BMI lower or equal to 32 kg/m2 ? Patients having signed a written informed consent, ? Well-informed of the study procedures, cooperative with regard to compliance with study related constraints, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Criteria related to pathologies ? Known acute or chronic prostate pathology, and/or PSA > 2 ng/mL, and/or suspicion of prostate cancer; familial history of prostate cancer, ? Male breast cancer, ? Severe cardiovascular, respiratory, hepatic, renal failure, or metabolic diseases/disorders, ? Non stabilized hypertension (> 160/90 mm Hg), ? Generalized dermatological disorders that might affect testosterone absorption or local tolerability assessment (hirsutism, psoriasis, eczema), ? ALT and/or AST twice above the upper limit; Hematocrit > 51%, ? Unbalanced diabetic patients (type I or II), ? Psychiatric disease, ? Organic cerebral disease (epilepsy, migraine), ? Sleep apnea, ? History of allergy to patches. * Criteria related to treatments ? Other concomitant patch treatment or other androgen replacement therapy, ? Concomitant treatment with barbiturates, ketoconazole, spironolactone, oral anticoagulants, finasteride, anti-androgens, LH-RH analogues, treatment influencing erection or testosterone level, and with any other medication known to alter the cytochrome P450 enzyme systems, ? Corticosteroids when used topically or as immunosuppresors (they are authorized when used in physiological doses as replacement therapy in secondary adrenal insufficiency. e.g cortisol < 30 mg or prednisone < 5 mg). * Criteria related to the way of life ? History of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare mean serum total testosterone levels over the last 48 hrs of a 22-day treatment with L0074 TD versus Pantestone®.;Secondary Objective: ? To compare mean serum total testosterone levels over the first 48 hrs of a 22-day treatment with L0074 TD versus Pantestone®. ? To compare, for each treatment, the mean serum total testosterone levels obtained over the first 48 hrs and the last 48 hrs of a 22-day treatment period. ? To compare the ability of both treatments to maintain physiological TT serum levels over the first 48 hrs and the last 48 hrs of a 22-day treatment period. ? To compare the ability of both treatments to maintain physiological levels of bioavailable testosterone (BT) over the first 48 hrs and the last 48 hrs of a 22-day treatment period. ? To compare the ability of both treatments to maintain physiological levels of DHT over the first 48 hrs and the last 48 hrs of a 22-day treatment period. ? To compare LH, FSH and SHBG serum levels at the end of each treatment period. ;Primary end point(s): Average TT serum level over the last 48 hours of each treatment period | — |
Countries
Spain
Outcome results
None listed