Male contraceptive and method of achieving male contraception

DETAILED DESCRIPTION I claim: 1.
A method of immunization of human males to achieve contraception which includes the step of administering, periodically, predetermined amounts of, non-primate, highly purified FSH having a biologic potency of at least 1,000 I.
U.
/mg.
, an LH contamination of below 11 I.
U.
/mg.
and a TSH contamination of less than 0.
1 I.
U.
/mg.
to a human male until his sperm production declines below about twenty million per cc.
2.
The method of claim 1 wherein said non-primate highly purified FSH is administered intramuscularly to the patient in an alum precipitate.
3.
The method of claim 1 wherein said highly purified FSH is derived from sheep pituitary glands.
4.
The method of claim 1 wherein said highly purified FSH is derived from rat pituitary glands having a biologic potency of at least 3750 I.
U.
/mg.
5.
A contraceptive preparation for the reduction of sperm production which consists essentially of: a predetermined quantity of a non-primate, highly purified FSH having a biologic potency of at least 1,000 I.
U/mg.
, an LH contamination of below 11 I.
U/mg.
and a TSH contamination of less than 0.
1 I.
U/mg.




Description:
SUMMARY OF THE INVENTION Extensive laboratory and clinical data indicate that FSH is the primary agent in stimulating and regulating sperm production, but FSH does not affect secretion of the male sex hormone, testosterone.
Therefore, active immunization of normal human males with sheep or rat FSH will result in formation of antibodies which will neutralize the subjects endogenous FSH secretion, such that the subject's sperm production will decline and infertility or contraception will result.
Androgen production and potency will be unaffected.
With occasional "booster" immunizations, the effect can be maintained permanently.
Without "booster" immunizations, the effect will "wear off.
" Highly purified FSH will be administered as an "alum precipitated"* antigen in a dose of 0.
5 mg.
three times monthly to normal human males, until suitably high titers of antibodies are generated, i