- Male subject unwilling to abstain from, or use a condom during sexual intercourse with a pregnant or lactating female; or male subject unwilling to use a condom plus another form of contraception (e.g., spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide) during sexual intercourse with a female who could become pregnant. Any male subject unwilling to adhere to the above contraceptive criteria from administration of study medication until completion of follow-up procedures.