Females of childbearing potential not using a medically acceptable means of contraception.
For female subjects of childbearing potential:
Females of childbearing potential who:
Be of non-childbearing potential:
Or, if of childbearing potential,
Female subjects of childbearing potential must:
Pregnant or breast-feeding women; women of childbearing potential with either a positive or no pregnancy test at baseline; woman or men of childbearing potential not using a reliable and appropriate contraceptive method; (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Not a woman of childbearing potential (WOCBP) as defined in protocol OR
Willingness to use contraception if childbearing potential
Females of childbearing potential must agree and meet the following conditions below: to
Females of childbearing potential who:
Any woman of childbearing potential, unless she:
Patients must be willing to use contraception if they have childbearing potential
Pregnancy, or unwillingness to use contraception if they have childbearing potential
Be of non-childbearing potential:
Or, if of childbearing potential,
Women of childbearing potential must
Patients must be willing to use contraception if they have childbearing potential
Women of childbearing potential
Patients must be willing to use contraception if they have childbearing potential
Patients of childbearing potential must practice appropriate contraception
Patients must be willing to use contraception if they have childbearing potential
Patients must be willing to use contraception if they have childbearing potential
Be of non-childbearing potential:
Or, if of childbearing potential:
Female participant without childbearing potential must meet at least one of the following:
Female participant of childbearing potential must meet at least one of the following:
Male or female patients of childbearing potential must be willing to use contraceptive precautions throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Female subjects must be of non-childbearing potential; women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >= 1 year
Or, if of childbearing potential,
Female subjects of childbearing potential must not be pregnant at screening.
Females of childbearing potential who:
3. Female subjects of childbearing potential1 may participate, providing they meet the following conditions:
Not a woman of childbearing potential as defined in Appendix VIII OR
Or, if of childbearing potential,
Female participants of childbearing potential must not be pregnant at screening
Patients must be willing to use contraception if they have childbearing potential
Or, if of childbearing potential,
A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if she is of childbearing potential
Female subjects of childbearing potential must not be pregnant at screening.
Patients must be willing to use contraception if they have childbearing potential
Pregnancy, or unwillingness to use contraception if they are have childbearing potential
Female participants of non-childbearing potential, ?18 years of age
Or, if of childbearing potential,
Male or non-childbearing potential females, (female patients who meet at least one of the following criteria are defined as women of non-childbearing potential)\r\n* >= 50 years old and naturally amenorrheic for >= 1 year\r\n* Permanent premature ovarian failure confirmed by specialist gynecologist\r\n* Previous bilateral salpingo-oophorectomy or hysterectomy\r\n* XY karyotype, Turner’s syndrome, or uterine agenesis
Women of childbearing potential
Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years
Women of childbearing potential and men with female sexual partners of childbearing potential must agree to abstain from sexual intercourse or use a double barrier method to determine if a woman is of childbearing potential (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).
A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
Or, if of childbearing potential,
Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) from screening through 3 months after taking the final dose of RTA 408;
Pregnant or lactating women are not eligible; women or men of childbearing potential not using a reliable and appropriate contraceptive method are not eligible (postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
Or, if of childbearing potential:
Females of childbearing potential who:
Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least 30 days after the last dose of the study drug
Note:  We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question
For female patients of childbearing potential, all of the following criteria must be met:
If the participant is of childbearing potential, she should be at least 3 months postpartum
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled inthe study, if the subject:
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Women of childbearing potential (WOCBP) must not be pregnant
Patient must have non-pregnant status if a female of childbearing potential; women who have had a tubal ligation of at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential; postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential
Or, if of childbearing potential,
Non-Childbearing Potential: Male subjects and their partners must meet one of the following criteria to be considered of non-childbearing potential: