An oral regimen of cyproterone acetate and testosterone undecanoate for spermatogenic suppression in men
Date
1997-11Author
Pavani, Anna
Costantino, Antonietta
Flamigni, Carlo
Capelli, Maurizio
Meriggiola, M. Cristina
Bremner, William J.
Metadata
Show full item recordAbstract
OBJECTIVE: To test the effectiveness, safety, and reversibility of the
combined administration of cyproterone acetate and T undecanoate. DESIGN:
Open clinical trial. SETTING: Healthy volunteers in an academic research
environment. PATIENT(S): Eight healthy men, aged 25-42 years were
selected. INTERVENTION(S): Cyproterone acetate, 12.5 mg, and T
undecanoate, 80 mg, were administered orally twice daily for 16 weeks.
MAIN OUTCOME MEASURE(S): 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. RESULT(S): 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. CONCLUSION(S): 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.