Female subject must agree not to breastfeed at screening and throughout the study period and for 45 days after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
Female participants must agree not to breastfeed or donate ova throughout the study drug treatment period and for 6 months after the final study drug administration.
Male participants must not donate sperm throughout the study drug treatment period and for 127 days after the final study drug administration.
If of reproductive potential, agrees to use a highly effective from of contraception or avoid intercourse during and upon completion of the study and for at least 4 months after the last dose of study drug, and agrees not to retrieve, freeze or donate sperm or ova starting at Screening and throughout the study period, and at least 4 months after the final study drug administration
Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and, for 90 days after the final study drug administration.
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and, for 6 months after the final study drug administration Note: *Highly effective forms of birth control include:
Is not breastfeeding at screening and will not breastfeed throughout the study period and for at least 3 months after final drug administration
Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study treatment administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
Agree to use a male condom starting at screening and continue throughout study treatment and for 6 months after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and for 6 months after the final study drug administration.
Female subject must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and 120 days after the final study drug administration.
In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.
Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
Female subject must not be breastfeeding at Screening or during the study period and for 3 months after final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final drug administration.
Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and for 120 days after the final study drug administration.
Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.
Female subject must agree not to breastfeed at screening and throughout the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period, and for 90 days after the final study drug administration.
Must not donate sperm from screening through 3 months after final study drug administration.
Female subject must not be breastfeeding at screening or during the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period and for 60 days after final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after final study drug administration.
Female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration. *Acceptable forms of birth control include:
Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 6 months after the final study drug administration.
Male participants (even if surgically sterilized), and partners who are women of childbearing potential must be using highly effective contraception in addition to a barrier method throughout the study drug treatment period and for 127 days after the final study drug administration.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 6 months after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception* consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 6 months after the final study drug administration
Agreement to exercise appropriate use of contraception. Subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued
Agreement to exercise appropriate use of contraception; subjects should use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at the time of screening for an enzalutamide study and continuing throughout the course of treatment and for at least three months after enzalutamide is discontinued
Male patients and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:
if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 6 months after the final study drug administration.
Male subject has not had a vasectomy or is not sterile as defined below, subject's female partner(s) is utilizing 1 form of highly effective birth control*starting at Screening and continue throughout study treatment and for 6 months after the subject receives final study drug administration
Sexually active women of childbearing age and men should be willing to use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing through 3 months after the final study drugs administration; men must agree to avoid sperm donation while on study and 3 months after the final study drugs administration
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing through 3 months after the final study drugs administration
And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and throughout the study period and for 180 days after the final study drug administration.
Male subject and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and continue throughout the study period and for 120 days after the final study drug administration.
Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include:
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
And, if heterosexually active, agree to consistently use 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and throughout the study period and for 180 days after the final study drug administration.
Male subject and their female partners who are of childbearing potential must be using 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; patients are also required to use a condom if having sex with a pregnant woman
Male subject and his female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration.
must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration. *Acceptable forms of birth control include:
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 120 days after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
Subjects and spouse/partner who are of childbearing potential must be using high effective contraception consisting of 2 forms of birth control (at least 1 of which much be barrier method) starting at Screening and continuing through the entire study (for at least 3 months after the last dose of ALXN1007 if study treatment is stopped early or subject withdraws consent).
And if heterosexually active, agrees to consistently use 1 form of highly effective birth control* starting at screening and throughout the study period and for 28 days after the final study drug administration.
Agrees to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile as defined below their female partner(s) is utilizing 1 form of highly effective birth control*starting at screening and continue throughout study treatment and for 90 days after the male subject receives their final study drug administration.
Throughout the study, male patients and their female partners of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
Throughout study, male subject and a female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
Male subject and a female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 120 days after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
If heterosexually active must use two forms of birth control* (at least one of which must be a barrier method) starting at screening and throughout the study period and for 28 days after the final study drug administration.
Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after the final study drug administration.
A male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
Male patients must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 60 days after the final study drug administration.
Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and throughout the study period and for 6 months after the final study drug administration.
Male subject and subject's female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration.
Agree not to try to become pregnant during the study for 6 months after the final study drug administration
Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
Agree not to try to become pregnant during the study and for 6 months after the final study drug administration
agree not to try to become pregnant during the study and for 6 months after the final study treatment administration,
Agree not to try to become pregnant during the study and for 180 days after the final study administration
Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 180 days after the final study drug administration; And have a negative urine pregnancy test at Day 1; And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration.
Agree not to try to become pregnant during the study and for 180 days after the final study drug administration
must agree not to try to become pregnant during the study and for 180 days after the final study drug administration, and
Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; And have a negative serum pregnancy test at Screening; And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a highly effective method and one must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
Or, if of childbearing potential: agree not to try to become pregnant during the study and for 60 days after the final study drug administration and have a negative serum or urine pregnancy test at screening, and if heterosexually active, agree to consistently use 2 forms of birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and for 60 days after final study drug administration.
agree not to try to become pregnant during the study and for 90 days after the final study drug administration;
Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
Agree not to try to become pregnant during the study and for 6 months after the final study drug administration