Oral Testosterone Decanoate (Andriol(R)) Supplement Therapy Improve the Quality of Life in the Men with Testosterone Deficiency

Park, Nam Cheol; Yan, Bo Quan; Chung, Jae Min; Lee, Kyeong Mi

Abstract

PURPOSE: We evaluated the changes in quality of life after administering an oral testosterone supplement to men with testosterone deficiencies.
MATERIALS and METHODS
The changes of subjective symptoms were estimated in 39 cases (33 cases in the experimental group and 6 cases in the placebo group) of testosterone definiency,in men who were treated with oral testosterone undecanoate (Andriol(R)) or a placebo by the single blind method from March 2001 to January 2002. The 80mg dose of oral testosterone was administered twice daily in a period of three months. Digital rectal examinations and laboratory tests including serum testosterone, PSA, cholesterol, AST and ALT were conducted on pretreatment and during the 1st and 3rd months after treatment. The changes in quality of life were evaluated on pretreatment and monthly after treatment by the PNUH QOL Scoring System, which consisted of 21 question sinquiring about the following 7 functions: metabolic, cardiopulmonary, musculoskeletal, gastroinestinal, neurologic and psychiatric and sexual. The Saint Louis University Questionnaire was used simultaneously to evaluate the changes in quality of life.
RESULTS
The 39 cases showed a 19~64 years old age distribution (mean 45.9 years old). Underlying causes of testosterone deficiency were primary hypogonadism and andropause in 10 and 29 cases, respectively. During the follow-up period, the drop-out after treatment in the experimental group was 4 cases due to low compliance or personal reasons. Serum testosterone was significantly increased in the each month of posttreatment compared to pretreatment levels only in the experimental group (p<0.05). No abnormal finding was detected on digital rectal examination or in serum PSA, cholesterol, AST and ALT levels in either guoup. Sexual dysfunction was the most common problem prior to treatment, followed by metabolic, psychatric, musculoskeletal, neurologic, gastrointestinal and cardiopulmonary dysfunction, in order. After treatment, sexual dysfunction showed the most improvement in symptom score followed by cardiopulmonary, metabolic, cardiopulmonary, musculoskeletal, and gastrointestinal functions showed significantly more improved symptom scores in the experimental group than in the control group. The positive rate of Saint Louis University Questionnaire significantly decreased in the posttreatment compared to pretreatment levels only in the experimental group (p<0.05). The complications were nonspecific symptoms such as gastrointestinal problems and fatigue in 3 cases, and acne, urticatria and joint pain in 1 case of the experimental group. But, they were self-limited and did not cause drop-out.
CONCLUSIONS
Androgen supplement therapy with oral testosterone undecanoate (Andriol(R)) enhanced the quality of life through the improvement of general body functions including physical functions and mental functions in men with testosterone deficiencies.