Females able to have children Sample Clauses

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 60 days after the last dose. • Implantable progesterone-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Combined (estrogen- and progestogen-containing) hormonal birth control o Oral* o Intravaginal* o Transdermal* • Progestogen-containing hormonal contraception o Oral* o Injectable* • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier method) You must agree to the following during the study and for at least 60 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier as detailed below: • Must agree to use a male condom when having sexual intercourse with a woman able to have children In addition to male condom use, a highly effective method of birth control may be considered for female partners able to have children, such as the methods detailed earlier in this document. The effects of the study drug on the following are not known and may involve unforeseeable risks: • Sperm • Ova • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance that you or your partner could become pregnant. If you or your partner are pregnant or become pregnant during the study, the study drug or procedures may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: • You are currently pregnant, planning to become pregnant, or are breastfeeding a child • ...
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Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Low user dependency methods (methods that do not rely on you to remember to use them) • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed)
Sample 1
Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing, during the study, and for at least 28 days after the last dose of study drug. Please note that carbamazepine can make hormonal birth control less effective. You will not be allowed to use hormonal methods of birth control during the study and for at least 28 days after the last dose. • Intrauterine device (IUD) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Sexual abstinence - defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant.
Sample 1
Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose. For hormonal birth control, you must not change the drug or the dose for at least 1 month before the start of study of dosing and throughout the study. • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* (See Note Below) • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier method) No birth control methods are required by males in this study. The effects of the study drugs on the following are not known and may involve unforeseeable risks: • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance that you could become pregnant. If you are pregnant or become pregnant during the study, the study drug or procedures may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: • You are currently pregnant, planning to become pregnant, or are breastfeeding a child If you want to stop your required birth control during the study, you should tell the study investigator
Sample 1
Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 450 days after the last dose of study drug. • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* (See Note below) • Sexual abstinence – defined as refraining from heterosexual intercourse during the study and until you are discharged from the study, and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the use of • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) No birth control methods are required for male participants in this study.
Sample 1

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