About Clinical Research
Study #51823

• Female participants who are sexually active and of childbearing potential (i.e., not surgically sterile at least 6 months prior to Check-in nor post-menopausal with amenorrhea for at least 1 year prior to Check-in and FSH levels consistent with postmenopausal status) must not be lactating and must have been using one of the following forms of contraception from 3 months before first study product administration through 30 days after the final administration of study product:
o hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in, when used in combination with male condoms with spermicide (use of NuvaRing® is at the Investigator’s discretion)
o double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to Check-in
o intrauterine device or system (utilize Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to Check-in
o exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to Check-in
Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in
line with the preferred and usual lifestyle of the participant. Female participants of
childbearing potential who are not currently engaging in heterosexual intercourse must
agree to use one of the above methods of birth control through completion of study, in the
event that they have heterosexual intercourse during the course of the study.

• Female participants who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check-in:
o hysteroscopic sterilization with documentation of success with hysterosalpingogram
o bilateral tubal ligation or bilateral salpingectomy
o hysterectomy
o bilateral oophorectomy
o Essure®
o or be post-menopausal with amenorrhea for at least 1 year prior to Check-in and confirmed by FSH levels consistent with post-menopausal status.

• exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to Check-in

• Female participants who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check-in:

• hysteroscopic sterilization with documentation of success with hysterosalpingogram

• bilateral tubal ligation or bilateral salpingectomy

• hysterectomy

• bilateral oophorectomy

• Essure®

or be post-menopausal with amenorrhea for at least 1 year prior to Check-in and confirmed by FSH levels consistent with post-menopausal status.