An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men.
OBJECTIVE
To test the effectiveness, safety, and reversibility of the combined administration of cyproterone acetate and T undecanoate.


METHODS
Open clinical trial.


METHODS
Healthy volunteers in an academic research environment.


METHODS
Eight healthy men, aged 25-42 years were selected.


METHODS
Cyproterone acetate, 12.5 mg, and T undecanoate, 80 mg, were administered orally twice daily for 16 weeks.


METHODS
Semen analyses every 2 weeks; physical examination, chemistries, hematology, prostatic-specific antigen, gonadotropins and T levels, and a questionnaire on sexual and behavioral function every 4 weeks.


RESULTS
In all subjects a profound suppression of spermatogenesis occurred; one subject became azoospermic, five subjects had sperm counts of < or = 3 x 10(6)/mL, and in two subjects sperm counts were 4 and 6 x 10(6)/mL in week 16. Sperm counts returned to baseline in all men after hormone administration was discontinued. No changes in metabolic parameters and total prostatic-specific antigen were detected. Hemoglobin and hematocrit decreased statistically significantly at week 16 of treatment and returned to baseline by week 12 of recovery. There was no change in sexual function or behavior.


CONCLUSIONS
The oral administration of T undecanoate plus cyproterone acetate induces a profound suppression of spermatogenesis with no major adverse effects. These data suggest the feasibility of oral contraception in men.
Meriggiola
M C
MC
Department of Obstetrics and Gynecology, S. Orsola Hospital, Bologna, Italy. crismeri@tin.it
Bremner
W J
WJ
Costantino
A
A
Pavani
A
A
Capelli
M
M
Flamigni
C
C
D000328:Adult; D003272:Contraceptive Agents, Male / Q000008:administration & dosage* / Q000009:adverse effects; D017373:Cyproterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects; D005640:Follicle Stimulating Hormone / Q000097:blood; D006400:Hematocrit; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D013076:Sperm Count; D013091:Spermatogenesis / Q000187:drug effects*; D013737:Testis / Q000033:anatomy & histology; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood; D045165:Testosterone Congeners
D003272:Contraceptive Agents, Male; D006454:Hemoglobins; D045165:Testosterone Congeners; D013739:Testosterone; D017373:Cyproterone Acetate; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; C010792:testosterone undecanoate