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 • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator
Appears in 1 contract
Samples: Informed Consent Document
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 28 days after the last dosedose of study drug. Please note that ritonavir can make estradiol-containing birth control less effective. A barrier method or other nonhormonal method of birth control must also be used if you are using estradiol-containing birth control. • Implantable progesteroneprogestogen-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 Hormonal birth control* (estrogen- and progestogen-containingSee Note below) 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 during the study and for 28 days after the last dose of study drug, 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 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-double barrier method) You must agree to the following during the study and for at least 60 28 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children 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 Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a woman female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered for in female partners able to have children, children of male participants such as the methods detailed earlier in this document. document The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Sperm • Ova Fertility • Pregnancy • Unborn child • Breastfeeding child The study drug taken with ritonavir has not been studied in pregnant or lactating women. It is unknown if it can cause harm to an unborn child or if it is secreted in human milk. Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this study. An appropriate method of birth control is required. 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 procedure 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 • You If you are a man whose female partner is currently pregnant or planning plan to become pregnant father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator
Appears in 1 contract
Samples: Informed Consent Document
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 28 days after the last dosedose of study drug. • Implantable progesteronePlease note that carbamazepine can make hormonal contraceptives less effective. It is suggested that a back-only hormone up method of birth control be utilized, such as a condom. 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) • Copper 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 28 days after the last dose of study drug: . • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children 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 Agree to use a male condom when having sexual intercourse with a woman female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered for in female partners able to have children, children of male participants such as the methods detailed earlier in this document. 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 The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance that you or your partner partner, could become pregnant. If you or your partner are pregnant or become pregnant pregnant, during the study, the study drug drugs or procedures procedure may involve unforeseeable risks to the unborn child. A \A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: • You If you are currently pregnant, planning plan to become pregnant, or are breastfeeding a child • You child, you should not join this study. If you are a man whose female partner is currently pregnant or planning plan to become pregnant father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator
Appears in 1 contract
Samples: Informed Consent Agreement
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 28 days after the last dosedose of study vaccine. • Implantable progesteroneprogestogen-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 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 of female condom 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 28 days after the last dose of study drugvaccine: • 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 You must agree to use birth control/barrier as detailed below: • Must agree Agree to use a male condom when having sexual intercourse with a woman female able to have children In addition to male condom usewho is not currently pregnant • Have had a vasectomy, a highly effective method with the absence of birth control may be considered for female partners able to have children, such as the methods detailed earlier in this document. sperm having been confirmed The effects of the study drug vaccine 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 is pregnant or become becomes pregnant during the study, the study drug vaccine or procedures procedure 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 • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator
Appears in 1 contract
Samples: Informed Consent Document
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 28 days after the last dosedose of study drug. • Please note that ritonavir can make estradiol-containing birth control less effective. A barrier method or other nonhormonal method of birth control must also be used if you are using estradiol-containing birth control. Implantable progesteroneprogestogen-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 Hormonal birth control* (estrogen- and progestogen-containingSee Note below) 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 during the study and for 28 days after the last dose of study drug, 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 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-double barrier method) You must agree to the following during the study and for at least 60 28 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children 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 Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a woman female able to have children who is not currently pregnant In addition to male condom use, a highly effective method of birth control may be considered for in female partners able to have children, children of male participants such as the methods detailed earlier in this document. document The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Sperm • Ova • Fertility Pregnancy • Unborn child • Breastfeeding child The study drug taken with ritonavir has not been studied in pregnant or lactating women. It is unknown if it can cause harm to an unborn child or if it is secreted in human milk. Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this study. An appropriate method of birth control is required. 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 procedure 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 If you are currently pregnant, planning plan to become pregnant, or are breastfeeding a child • You child, you should not join this study. If you are a man whose female partner is currently pregnant or planning plan to become pregnant father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator
Appears in 1 contract
Samples: Informed Consent Document
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 28 days after the last dosedosing. • Implantable progesteroneprogestogen-only hormone hormonal 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 Hormonal birth control o Oral* o Intravaginal* o Transdermal* • Progestogen-containing hormonal contraception o Oral* o Injectable* (*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 of female condom with or without spermicide • Cervical cap, diaphragm, or sponge with or without 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 28 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse with a female able to have children 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 who is able to have children who is not currently pregnant In addition to male condom use, a female partners able to have children may consider an additional 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 • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigatorabove.
Appears in 1 contract
Samples: Informed Consent Agreement
