CROSS-OVER COMPARISON OF TESTOSTERONE SERUM LEVELS IN HYPOGONADAL MEN TREATED WITH L0074 TESTOSTERONE PATCH 60CM2 (2 patches/48H) AND ORAL TESTOSTERONE UNDECANOATE -PANTESTONE® 40mg- (2 caps, bid) - NA

Phase 1

• Conditions: Men aged > 18 years old with primary or secondary hypogonadism.Only patients meeting the inclusion criteria will be enrolled in this study.; MedDRA version: 7.1Level: PTClassification code 10021011

• Registration Number: EUCTR2004-004891-36-ES
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-09-19
• Study Start: 2005-11-04
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 55

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

*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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified